Packages

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

Weitere Informationen sind unter Stammdaten UDI beschrieben.


Verwendung dieses Programms

Felder

Überschriftsformat

Feldbezeichnung Erklärung
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.

Container package(s)

Feldbezeichnung Erklärung
Package DI Number

A device identifier for the package configuration that contains multiple units of the base package (does not include shipping containers).

For example: 4 glove boxes in a Carton -- Package DI =201 (the UDI on the Carton) 5 Cartons in a Case -- Package DI=301 (the UDI on the Case) contains a 5 cartons (with DI 201) with 4 glove boxes in a carton 10 glove boxes in a Carton -- Package DI=202 (the UDI on the Carton).
Issuing Entity Issuing agency code for the issuer as defined by SO/IEC 15459.
Quantity per package Anzahl der Positionen in der Verpackungsstruktur. Wird verwendet, wenn die Verpackungsstruktur eines Geräts beschrieben werden soll.
Related Package DI
Container Packaging Structure is a hierarchical structure defining how the Device is packaged together for shipping and selling reasons. The basic (the lower) element of the Packaging Structure is the UDI-DI.

The field stores a link to previous element in the Package Structure (parent element).
Device Status Status of the Device (On the market, No longer placed on the market).
Date of Status Date when the Status/ Substatus is updated.

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