DeviceDefinition

The characteristics, operational status and capabilities of a medical-related component of a medical device.

Columns

Header row
# path type required description
0 resourceType string * Resource type identifier. Must be string "DeviceDefinition"
1 integer * Number of subrows
2 id string * Logical id of this artifact
manufacturer[x] Name of device manufacturer
3 manufacturerString string
manufacturerReference Reference
4 manufacturerReference.reference string Literal reference, Relative, internal or absolute URL
5 manufacturerReference.type uri Type the reference refers to (e.g. "Patient")
manufacturerReference.identifier Identifier Logical reference, when literal reference is not known
6 manufacturerReference.identifier.use code usual | official | temp | secondary | old (If known)
manufacturerReference.identifier.type CodeableConcept Description of identifier
manufacturerReference.identifier.type.coding Coding Code defined by a terminology system
7 manufacturerReference.identifier.type.coding.system uri Identity of the terminology system
8 manufacturerReference.identifier.type.coding.version string Version of the system - if relevant
9 manufacturerReference.identifier.type.coding.code code Symbol in syntax defined by the system
10 manufacturerReference.identifier.type.coding.display string Representation defined by the system
11 manufacturerReference.identifier.type.coding.userSelected boolean If this coding was chosen directly by the user
12 manufacturerReference.identifier.type.text string Plain text representation of the concept
13 manufacturerReference.identifier.system uri The namespace for the identifier value
14 manufacturerReference.identifier.value string The value that is unique
manufacturerReference.identifier.period Period Time period when id is/was valid for use
15 manufacturerReference.identifier.period.start dateTime Starting time with inclusive boundary
16 manufacturerReference.identifier.period.end dateTime End time with inclusive boundary, if not ongoing
17 manufacturerReference.display string Text alternative for the resource
18 modelNumber string The model number for the device
type CodeableConcept What kind of device or device system this is
type.coding Coding Code defined by a terminology system
19 type.coding.system uri Identity of the terminology system
20 type.coding.version string Version of the system - if relevant
21 type.coding.code code Symbol in syntax defined by the system
22 type.coding.display string Representation defined by the system
23 type.coding.userSelected boolean If this coding was chosen directly by the user
24 type.text string Plain text representation of the concept
physicalCharacteristics ProdCharacteristic Dimensions, color etc.
physicalCharacteristics.height Quantity Where applicable, the height can be specified using a numerical value and its unit of measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
25 physicalCharacteristics.height.value decimal Numerical value (with implicit precision)
26 physicalCharacteristics.height.comparator code < | <= | >= | > - how to understand the value
27 physicalCharacteristics.height.unit string Unit representation
28 physicalCharacteristics.height.system uri System that defines coded unit form
29 physicalCharacteristics.height.code code Coded form of the unit
physicalCharacteristics.width Quantity Where applicable, the width can be specified using a numerical value and its unit of measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
30 physicalCharacteristics.width.value decimal Numerical value (with implicit precision)
31 physicalCharacteristics.width.comparator code < | <= | >= | > - how to understand the value
32 physicalCharacteristics.width.unit string Unit representation
33 physicalCharacteristics.width.system uri System that defines coded unit form
34 physicalCharacteristics.width.code code Coded form of the unit
physicalCharacteristics.depth Quantity Where applicable, the depth can be specified using a numerical value and its unit of measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
35 physicalCharacteristics.depth.value decimal Numerical value (with implicit precision)
36 physicalCharacteristics.depth.comparator code < | <= | >= | > - how to understand the value
37 physicalCharacteristics.depth.unit string Unit representation
38 physicalCharacteristics.depth.system uri System that defines coded unit form
39 physicalCharacteristics.depth.code code Coded form of the unit
physicalCharacteristics.weight Quantity Where applicable, the weight can be specified using a numerical value and its unit of measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
40 physicalCharacteristics.weight.value decimal Numerical value (with implicit precision)
41 physicalCharacteristics.weight.comparator code < | <= | >= | > - how to understand the value
42 physicalCharacteristics.weight.unit string Unit representation
43 physicalCharacteristics.weight.system uri System that defines coded unit form
44 physicalCharacteristics.weight.code code Coded form of the unit
physicalCharacteristics.nominalVolume Quantity Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
45 physicalCharacteristics.nominalVolume.value decimal Numerical value (with implicit precision)
46 physicalCharacteristics.nominalVolume.comparator code < | <= | >= | > - how to understand the value
47 physicalCharacteristics.nominalVolume.unit string Unit representation
48 physicalCharacteristics.nominalVolume.system uri System that defines coded unit form
49 physicalCharacteristics.nominalVolume.code code Coded form of the unit
physicalCharacteristics.externalDiameter Quantity Where applicable, the external diameter can be specified using a numerical value and its unit of measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
50 physicalCharacteristics.externalDiameter.value decimal Numerical value (with implicit precision)
51 physicalCharacteristics.externalDiameter.comparator code < | <= | >= | > - how to understand the value
52 physicalCharacteristics.externalDiameter.unit string Unit representation
53 physicalCharacteristics.externalDiameter.system uri System that defines coded unit form
54 physicalCharacteristics.externalDiameter.code code Coded form of the unit
55 physicalCharacteristics.shape string Where applicable, the shape can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used
56 physicalCharacteristics.color string Where applicable, the color can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used
57 physicalCharacteristics.imprint string Where applicable, the imprint can be specified as text
physicalCharacteristics.image Attachment Where applicable, the image can be provided The format of the image attachment shall be specified by regional implementations
58 physicalCharacteristics.image.contentType code Mime type of the content, with charset etc.
59 physicalCharacteristics.image.language code Human language of the content (BCP-47)
60 physicalCharacteristics.image.data base64Binary Data inline, base64ed
61 physicalCharacteristics.image.url url Uri where the data can be found
62 physicalCharacteristics.image.size unsignedInt Number of bytes of content (if url provided)
63 physicalCharacteristics.image.hash base64Binary Hash of the data (sha-1, base64ed)
64 physicalCharacteristics.image.title string Label to display in place of the data
65 physicalCharacteristics.image.creation dateTime Date attachment was first created
physicalCharacteristics.scoring CodeableConcept Where applicable, the scoring can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used
physicalCharacteristics.scoring.coding Coding Code defined by a terminology system
66 physicalCharacteristics.scoring.coding.system uri Identity of the terminology system
67 physicalCharacteristics.scoring.coding.version string Version of the system - if relevant
68 physicalCharacteristics.scoring.coding.code code Symbol in syntax defined by the system
69 physicalCharacteristics.scoring.coding.display string Representation defined by the system
70 physicalCharacteristics.scoring.coding.userSelected boolean If this coding was chosen directly by the user
71 physicalCharacteristics.scoring.text string Plain text representation of the concept
owner Reference Organization responsible for device
72 owner.reference string Literal reference, Relative, internal or absolute URL
73 owner.type uri Type the reference refers to (e.g. "Patient")
owner.identifier Identifier Logical reference, when literal reference is not known
74 owner.identifier.use code usual | official | temp | secondary | old (If known)
owner.identifier.type CodeableConcept Description of identifier
owner.identifier.type.coding Coding Code defined by a terminology system
75 owner.identifier.type.coding.system uri Identity of the terminology system
76 owner.identifier.type.coding.version string Version of the system - if relevant
77 owner.identifier.type.coding.code code Symbol in syntax defined by the system
78 owner.identifier.type.coding.display string Representation defined by the system
79 owner.identifier.type.coding.userSelected boolean If this coding was chosen directly by the user
80 owner.identifier.type.text string Plain text representation of the concept
81 owner.identifier.system uri The namespace for the identifier value
82 owner.identifier.value string The value that is unique
owner.identifier.period Period Time period when id is/was valid for use
83 owner.identifier.period.start dateTime Starting time with inclusive boundary
84 owner.identifier.period.end dateTime End time with inclusive boundary, if not ongoing
85 owner.display string Text alternative for the resource
86 url uri Network address to contact device
87 onlineInformation uri Access to on-line information
quantity Quantity The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
88 quantity.value decimal Numerical value (with implicit precision)
89 quantity.comparator code < | <= | >= | > - how to understand the value
90 quantity.unit string Unit representation
91 quantity.system uri System that defines coded unit form
92 quantity.code code Coded form of the unit
parentDevice Reference The parent device it can be part of
93 parentDevice.reference string Literal reference, Relative, internal or absolute URL
94 parentDevice.type uri Type the reference refers to (e.g. "Patient")
parentDevice.identifier Identifier Logical reference, when literal reference is not known
95 parentDevice.identifier.use code usual | official | temp | secondary | old (If known)
parentDevice.identifier.type CodeableConcept Description of identifier
parentDevice.identifier.type.coding Coding Code defined by a terminology system
96 parentDevice.identifier.type.coding.system uri Identity of the terminology system
97 parentDevice.identifier.type.coding.version string Version of the system - if relevant
98 parentDevice.identifier.type.coding.code code Symbol in syntax defined by the system
99 parentDevice.identifier.type.coding.display string Representation defined by the system
100 parentDevice.identifier.type.coding.userSelected boolean If this coding was chosen directly by the user
101 parentDevice.identifier.type.text string Plain text representation of the concept
102 parentDevice.identifier.system uri The namespace for the identifier value
103 parentDevice.identifier.value string The value that is unique
parentDevice.identifier.period Period Time period when id is/was valid for use
104 parentDevice.identifier.period.start dateTime Starting time with inclusive boundary
105 parentDevice.identifier.period.end dateTime End time with inclusive boundary, if not ongoing
106 parentDevice.display string Text alternative for the resource
Row identifier
# path type required description
0 string * Subrow identifier. Must be string "identifier"
identifier Identifier Instance identifier
1 identifier.use code usual | official | temp | secondary | old (If known)
identifier.type CodeableConcept Description of identifier
identifier.type.coding Coding Code defined by a terminology system
2 identifier.type.coding.system uri Identity of the terminology system
3 identifier.type.coding.version string Version of the system - if relevant
4 identifier.type.coding.code code Symbol in syntax defined by the system
5 identifier.type.coding.display string Representation defined by the system
6 identifier.type.coding.userSelected boolean If this coding was chosen directly by the user
7 identifier.type.text string Plain text representation of the concept
8 identifier.system uri The namespace for the identifier value
9 identifier.value string The value that is unique
identifier.period Period Time period when id is/was valid for use
10 identifier.period.start dateTime Starting time with inclusive boundary
11 identifier.period.end dateTime End time with inclusive boundary, if not ongoing
Row udiDeviceIdentifier
# path type required description
0 string * Subrow identifier. Must be string "udiDeviceIdentifier"
udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string
1 udiDeviceIdentifier.deviceIdentifier string The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
2 udiDeviceIdentifier.issuer uri The organization that assigns the identifier algorithm
3 udiDeviceIdentifier.jurisdiction uri The jurisdiction to which the deviceIdentifier applies
Row deviceName
# path type required description
0 string * Subrow identifier. Must be string "deviceName"
deviceName A name given to the device to identify it
1 deviceName.name string The name of the device
2 deviceName.type code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Row specialization
# path type required description
0 string * Subrow identifier. Must be string "specialization"
specialization The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
1 specialization.systemType string The standard that is used to operate and communicate
2 specialization.version string The version of the standard that is used to operate and communicate
Row version
# path type required description
0 string * Subrow identifier. Must be string "version"
1 version string Available versions
Row safety
# path type required description
0 string * Subrow identifier. Must be string "safety"
safety CodeableConcept Safety characteristics of the device
safety.coding Coding Code defined by a terminology system
1 safety.coding.system uri Identity of the terminology system
2 safety.coding.version string Version of the system - if relevant
3 safety.coding.code code Symbol in syntax defined by the system
4 safety.coding.display string Representation defined by the system
5 safety.coding.userSelected boolean If this coding was chosen directly by the user
6 safety.text string Plain text representation of the concept
Row shelfLifeStorage
# path type required description
0 string * Subrow identifier. Must be string "shelfLifeStorage"
shelfLifeStorage ProductShelfLife Shelf Life and storage information
shelfLifeStorage.identifier Identifier Unique identifier for the packaged Medicinal Product
1 shelfLifeStorage.identifier.use code usual | official | temp | secondary | old (If known)
shelfLifeStorage.identifier.type CodeableConcept Description of identifier
shelfLifeStorage.identifier.type.coding Coding Code defined by a terminology system
2 shelfLifeStorage.identifier.type.coding.system uri Identity of the terminology system
3 shelfLifeStorage.identifier.type.coding.version string Version of the system - if relevant
4 shelfLifeStorage.identifier.type.coding.code code Symbol in syntax defined by the system
5 shelfLifeStorage.identifier.type.coding.display string Representation defined by the system
6 shelfLifeStorage.identifier.type.coding.userSelected boolean If this coding was chosen directly by the user
7 shelfLifeStorage.identifier.type.text string Plain text representation of the concept
8 shelfLifeStorage.identifier.system uri The namespace for the identifier value
9 shelfLifeStorage.identifier.value string The value that is unique
shelfLifeStorage.identifier.period Period Time period when id is/was valid for use
10 shelfLifeStorage.identifier.period.start dateTime Starting time with inclusive boundary
11 shelfLifeStorage.identifier.period.end dateTime End time with inclusive boundary, if not ongoing
shelfLifeStorage.type CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
shelfLifeStorage.type.coding Coding Code defined by a terminology system
12 shelfLifeStorage.type.coding.system uri Identity of the terminology system
13 shelfLifeStorage.type.coding.version string Version of the system - if relevant
14 shelfLifeStorage.type.coding.code code Symbol in syntax defined by the system
15 shelfLifeStorage.type.coding.display string Representation defined by the system
16 shelfLifeStorage.type.coding.userSelected boolean If this coding was chosen directly by the user
17 shelfLifeStorage.type.text string Plain text representation of the concept
shelfLifeStorage.period Quantity The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
18 shelfLifeStorage.period.value decimal Numerical value (with implicit precision)
19 shelfLifeStorage.period.comparator code < | <= | >= | > - how to understand the value
20 shelfLifeStorage.period.unit string Unit representation
21 shelfLifeStorage.period.system uri System that defines coded unit form
22 shelfLifeStorage.period.code code Coded form of the unit
shelfLifeStorage.specialPrecautionsForStorage CodeableConcept Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
shelfLifeStorage.specialPrecautionsForStorage.coding Coding Code defined by a terminology system
23 shelfLifeStorage.specialPrecautionsForStorage.coding.system uri Identity of the terminology system
24 shelfLifeStorage.specialPrecautionsForStorage.coding.version string Version of the system - if relevant
25 shelfLifeStorage.specialPrecautionsForStorage.coding.code code Symbol in syntax defined by the system
26 shelfLifeStorage.specialPrecautionsForStorage.coding.display string Representation defined by the system
27 shelfLifeStorage.specialPrecautionsForStorage.coding.userSelected boolean If this coding was chosen directly by the user
28 shelfLifeStorage.specialPrecautionsForStorage.text string Plain text representation of the concept
Row languageCode
# path type required description
0 string * Subrow identifier. Must be string "languageCode"
languageCode CodeableConcept Language code for the human-readable text strings produced by the device (all supported)
languageCode.coding Coding Code defined by a terminology system
1 languageCode.coding.system uri Identity of the terminology system
2 languageCode.coding.version string Version of the system - if relevant
3 languageCode.coding.code code Symbol in syntax defined by the system
4 languageCode.coding.display string Representation defined by the system
5 languageCode.coding.userSelected boolean If this coding was chosen directly by the user
6 languageCode.text string Plain text representation of the concept
Row capability
# path type required description
0 string * Subrow identifier. Must be string "capability"
capability Device capabilities
capability.type CodeableConcept Type of capability
capability.type.coding Coding Code defined by a terminology system
1 capability.type.coding.system uri Identity of the terminology system
2 capability.type.coding.version string Version of the system - if relevant
3 capability.type.coding.code code Symbol in syntax defined by the system
4 capability.type.coding.display string Representation defined by the system
5 capability.type.coding.userSelected boolean If this coding was chosen directly by the user
6 capability.type.text string Plain text representation of the concept
capability.description CodeableConcept Description of capability
capability.description.coding Coding Code defined by a terminology system
7 capability.description.coding.system uri Identity of the terminology system
8 capability.description.coding.version string Version of the system - if relevant
9 capability.description.coding.code code Symbol in syntax defined by the system
10 capability.description.coding.display string Representation defined by the system
11 capability.description.coding.userSelected boolean If this coding was chosen directly by the user
12 capability.description.text string Plain text representation of the concept
Row property
# path type required description
0 string * Subrow identifier. Must be string "property"
property The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
property.type CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
property.type.coding Coding Code defined by a terminology system
1 property.type.coding.system uri Identity of the terminology system
2 property.type.coding.version string Version of the system - if relevant
3 property.type.coding.code code Symbol in syntax defined by the system
4 property.type.coding.display string Representation defined by the system
5 property.type.coding.userSelected boolean If this coding was chosen directly by the user
6 property.type.text string Plain text representation of the concept
property.valueQuantity Quantity Property value as a quantity
7 property.valueQuantity.value decimal Numerical value (with implicit precision)
8 property.valueQuantity.comparator code < | <= | >= | > - how to understand the value
9 property.valueQuantity.unit string Unit representation
10 property.valueQuantity.system uri System that defines coded unit form
11 property.valueQuantity.code code Coded form of the unit
property.valueCode CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
property.valueCode.coding Coding Code defined by a terminology system
12 property.valueCode.coding.system uri Identity of the terminology system
13 property.valueCode.coding.version string Version of the system - if relevant
14 property.valueCode.coding.code code Symbol in syntax defined by the system
15 property.valueCode.coding.display string Representation defined by the system
16 property.valueCode.coding.userSelected boolean If this coding was chosen directly by the user
17 property.valueCode.text string Plain text representation of the concept
Row contact
# path type required description
0 string * Subrow identifier. Must be string "contact"
contact ContactPoint Details for human/organization for support
1 contact.system code phone | fax | email | pager | url | sms | other
2 contact.value string The actual contact point details
3 contact.use code home | work | temp | old | mobile - purpose of this contact point
4 contact.rank positiveInt Specify preferred order of use (1 = highest)
contact.period Period Time period when the contact point was/is in use
5 contact.period.start dateTime Starting time with inclusive boundary
6 contact.period.end dateTime End time with inclusive boundary, if not ongoing
Row note
# path type required description
0 string * Subrow identifier. Must be string "note"
note Annotation Device notes and comments
note.author[x] Individual responsible for the annotation
note.authorReference Reference
1 note.authorReference.reference string Literal reference, Relative, internal or absolute URL
2 note.authorReference.type uri Type the reference refers to (e.g. "Patient")
note.authorReference.identifier Identifier Logical reference, when literal reference is not known
3 note.authorReference.identifier.use code usual | official | temp | secondary | old (If known)
note.authorReference.identifier.type CodeableConcept Description of identifier
note.authorReference.identifier.type.coding Coding Code defined by a terminology system
4 note.authorReference.identifier.type.coding.system uri Identity of the terminology system
5 note.authorReference.identifier.type.coding.version string Version of the system - if relevant
6 note.authorReference.identifier.type.coding.code code Symbol in syntax defined by the system
7 note.authorReference.identifier.type.coding.display string Representation defined by the system
8 note.authorReference.identifier.type.coding.userSelected boolean If this coding was chosen directly by the user
9 note.authorReference.identifier.type.text string Plain text representation of the concept
10 note.authorReference.identifier.system uri The namespace for the identifier value
11 note.authorReference.identifier.value string The value that is unique
note.authorReference.identifier.period Period Time period when id is/was valid for use
12 note.authorReference.identifier.period.start dateTime Starting time with inclusive boundary
13 note.authorReference.identifier.period.end dateTime End time with inclusive boundary, if not ongoing
14 note.authorReference.display string Text alternative for the resource
15 note.authorString string
16 note.time dateTime When the annotation was made
17 note.text markdown The annotation - text content (as markdown)
Row material
# path type required description
0 string * Subrow identifier. Must be string "material"
material A substance used to create the material(s) of which the device is made
material.substance CodeableConcept The substance
material.substance.coding Coding Code defined by a terminology system
1 material.substance.coding.system uri Identity of the terminology system
2 material.substance.coding.version string Version of the system - if relevant
3 material.substance.coding.code code Symbol in syntax defined by the system
4 material.substance.coding.display string Representation defined by the system
5 material.substance.coding.userSelected boolean If this coding was chosen directly by the user
6 material.substance.text string Plain text representation of the concept
7 material.alternate boolean Indicates an alternative material of the device
8 material.allergenicIndicator boolean Whether the substance is a known or suspected allergen

Examples

Example #1
Input CSV
DeviceDefinition,1,"example",,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,
identifier,,,,,,,,,"0",,
Resulting resource
{
  "resourceType": "DeviceDefinition",
  "id": "example",
  "identifier": [
    {
      "value": "0"
    }
  ]
}