Clinical Size

Hier können die UDI-DI spezifischen Informationen zu "Clinical Size" hinterlegt werden.

Weitere Informationen sind unter Stammdaten UDI beschrieben.


Verwendung dieses Programms

Felder

Überschriftsformat

FeldbezeichnungErklärung
Basic UDI-DI Device Identified code/value (DI Code). Together with the Issuing Entity creates the uniqness of the element to which they are assigned (Basic UDI-DI , UDI-DI, etc.). The Basic UDI-DI is the primary identifier of a device model.It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the 'access key' to information stored in a UDI database. The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
Primary DI Number
The Primary Device Identifier (DI) is the DI portion of the UDI placed on the lowest package level of a device that is required to meet UDI label requirements.  If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark (DM) requirement if the UDI is intended to be permanent.   The primary DI is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use.

Clinical Size

FeldbezeichnungErklärung
Clinical Size Type Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit. The Type of Clinical Size (example : length, width, etc.).
Precision Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit. Clinical Size Precision - mentions how the recording of Data will be performed (as value, range or Other is selected).
Value (Minimum) Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit. Value (Minimum) that the Clinical Size can get (when Value or Range is selected as precision).
Value (Maximum) Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit. Maximum Value that the Clinical Size can get (when Range is selected as precision).
Measure Unit Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit. Clinical Size Measure Unit.
Value (Text) Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit. Value that the Clinical Size can get (when Other is selected as precision).

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