Age QtyAvailable For Evaluation IndCE Mark IndDevice Risk TypeManufacture Date and TimeMaterial Handling TypeModel NameOver The Counter Product IndReprocessed DeviceReprocessor Return Date and TimeSingle Use Device IndSoftware Name
| Business Data Model Data Model |
| Description | A product that is intended for use alone or in combination with another product. A device can be used for diagnostic, prevention, monitoring, therapeutic, scientific, and/or experimental purposes. For example: Tongue depressor Pacemaker Insulin pump |
| Generalization | |
 R_1269 |
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| Dependencies | |
 NONE |
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| Reverse Dependencies | |
| |
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| Attribute Details |
Age Qty
| Description | A measure (or best estimate) of the length of time during which a device existed, measured from manufacture date (and time) to a given date (and time) of use. Derived from the difference between the manufacture date and the date of the activity in which it is used. This is not really a characteristic of the device since the device could be used in multiple activities. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Available For Evaluation Ind
| Description | Specifies whether or not the device is accessible for assessment by the manufacturer. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
CE Mark Ind
| Description | Specifies whether or not this device bears a CE (Conformite Europeenne) mark. CE is a mark for device products placed on the market in the European Economic Area (EEA). By placing the CE marking on a product, the manufacturer affirms that the product conforms with the requirements of the applicable European Community directives. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Device Risk Type
| Description | Indicates the type of hazard or threat associated with the device. For example: Flammable Explosive |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Manufacture Date and Time
| Description | The date and time that the device was made by the manufacturer. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Material Handling Type
| Description | Indicates any special handling requirement for the materials including drugs, biologic substances and devices. For example: Keep at room temperature Refrigerate Store upright Keep dry |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Model Name
| Description | Name or Identifier for a particular type of product. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Name Medium [VARCHAR(80)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Over The Counter Product Ind
| Description | Specifies whether or not a device is available over-the-counter. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Reprocessed Device
| Description | Indicates whether a device is reconditioned. For example: Initial use Reuse Unknown |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Reprocessor Return Date and Time
| Description | The date and time when a device is returned to its manufacturer or reprocessor. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Single Use Device Ind
| Description | Specifies whether or not a device is intended to be used only one time. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Software Name
| Description | Text description of a software product. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Name Medium [VARCHAR(80)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Generalization Details |
R_1269
| Supertype | Product |
| Subtype | Device |
| Transform As | TABLE |
| Business Data Model Data Model |