Verwaltungsprogramm UDI-DI
Mit diesem Programm können Sie einem Artikel eine oder mehrere UDI-DIs zuordnen und verwalten.
Weitere Informationen sind unter Stammdaten UDI beschrieben.
Verwendung dieses Programms
- US17000 Artikel
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. | ||||||||
| Issuing Entity | Organization accredited by FDA to operate a system for the issuance of UDIs. | ||||||||
| 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. | ||||||||
| Device Count | Number of medical devices in the base package. | ||||||||
| DI Record Status | Indicates the status of the DI Record. Value is one of the following:
| ||||||||
| Artikel | Der Artikel kann in allen Anwendungen erkannt und abgespeichert werden. Ein eindeutiger Verweis auf den zu verwendenden Artikel ist möglich, da die Artikelnummer in allen Bewegungsdateien gespeichert wird. Für den Artikel kann eine Nummer gezielt vom Benutzer oder fortlaufend vom System vergeben werden. Vorschriften über den Aufbau der Artikelnummer können im Firmenstamm in einer Aufbereitungsschablone hinterlegt werden. Ist der Artikel nicht bekannt, kann über den List-Button im Matchcode-Programm z.B. nach der Bezeichnung, Materialnummer, den Sachmerkmalen, dem Alpha-Suchbegriff, oder der Zeichnungsnummer gesucht werden. Viele Auskunfts- und Listprogramme können pro Artikel aufgerufen werden oder weisen als Ergebnis den Artikel aus. |
UDI-DI identification
| Feldbezeichnung | Erklärung |
|---|---|
| UDI-DI from another entity (secondary) applicable | |
| Issuing Entity Secondary DI | Name of Secondary DI Issuing Entity. |
| Secondary DI Number | An identifier that is an alternate (secondary) lookup for a medical device that is issued from a different issuing entity than the primary DI. Under 21 CFR 830.40(a), only one device identifier from any particular system for the issuance of UDIs may be used to identify a particular version or model of a device. |
| Trade Name | |
| Trade Name | A brand name is a trade/proprietary name assigned by the device labeler, and under which the device is sold, distinguished from other similar devices, and recognized by the user or purchaser. A brand name is often registered and/or protected by a trademark. |
| Reference / Catalogue Number | Property stores the Reference or Catalogue Number of the Device. |
| Direct marking | |
| Is the device directly marked? | The device is exempt from Direct Marking requirements under 21CFR 801.45. |
| Direct marking DI | An identifier that is permanently marked directly on the medical device. Certain devices are required to be directly marked. Under 21 CFR 801.45(b), the direct mark DI may be identical to or different from the Primary DI. |
| Issuing Entity DM DI | Issuing Entity Direct marking DI |
| Unit of Use | |
| Unit of Use DI Number | An unmarked identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient. The Unit of Use DI does not appear on the label of the device. |
| Type of UDI-PI | |
| Lot or Batch Number | Indicates the device is managed by lot or batch number. This number can be found on the device label or packaging. Lot or Batch means one finished device or more that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. |
| Software Version | Indicates that the Application Identifier data field contains a software version number. |
| Stand der Software | In diesem Feld wird der Softwarestand eingegeben. Der Softwarestand ist ein Begriff aus der Produktion und stellt eine spezifische Geräteinformation dar. |
| Serial Number | Indicates the device is managed by serial number. This number can be found on the device label or packaging. The serial number is assigned by the labeler and should be specific to each device. |
| Expiration Date | Indicates the device is managed by expiration date; the date by which the label of a device states that the device must or should be used. |
| Manufacturing Date | Indicates the device is managed by date of manufacture; the date a specific device was manufactured. |
| Additional information | |
| Additional product description | Additional Product Description. Additional Product Description is required for System or Procedure Packs or for Standard Devices being marked as System or Procedure Packs (as a Device in themselvs). |
| URL for additional information | Manufacturer`s website where additional information about the device (UDI-DI) are available. |
| DI Record Publish Date |
Indicates the date the DI Record is published and available via Public Search.
|
| Customer Contact | |
| Customer Contact Phone | Phone number for the Customer contact; to be used by patients and consumers for device-related questions. |
| Customer Contact E-Mail | Email for the Customer contact; to be used by patients and consumers for device-related questions. |
| Is the device designed and manufactured by another legal or natural person? | |
| SRN (Manufacturer) | SRN of the Product Designer |
| Address | Address of the Product Designer (applicable if the Product Designer does not have a SRN) |
| XML upload information | |
| Current Version (UDI-DI) | Current Version of the UDI-DI, which should be equal to the corresponding UDI-DI version in the EUDAMED database. |
| Last XML-Generation (UDI-DI) | Date of the last XML-generation (Upload of new Basic UDI-DI and UDI-DI or Upload of new UDI-DI for existing Basic UDI-DI or Update of an existing UDI-DI). |
| Current Version (Market Info) | Current Version of the Market Information, which should be equal to the corresponding Market Information version in the EUDAMED database. |
| Last XML-Generation (Market Info) | Date of the last XML-generation (Upload of new Basic UDI-DI and UDI-DI or Upload of new UDI-DI or Update of Market Information). |
UDI-DI information
| Feldbezeichnung | Erklärung |
|---|---|
| UDI-DI status | |
| 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. |
| Intended purpose other than medical (Annex XVI) | |
| Contact lenses | Contact Lenses- Annex XVI - Mentions purpose of Device other than medical - Contact Lenses |
| Products (introduced into the human body) | Products intended to be totally or partially introduced into the human body. |
| Substances (filling by injection) | Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing. |
| Equipment for Adipose Tissue | Equipment for Adipose Tissue Annex XVI - Mentions purpose of Device other than medical - Equipment for Adipose Tissue. |
| High intensity electromagnetic radiation | EMR- High intensity electromagnetic radiation - Annex XVI - Mentions purpose of Device other than medical (High intensity electromagnetic radiation). |
| Brain electrostimulation | BrainElectrostimulation - Annex XVI - Mentions purpose of Device other than medical - Brain electrostimulation. |
| UDI-DI characteristics | |
| Labelled as single use | Indicates that the device is intended for one use or on a single patient during a single procedure. |
| Maximum number of reuses | Property defines the Maximum Number of reuses applicable for the Device. Field is optional and can be completed if the Device is not marked as single use device ( singleUse is false). |
| Need for sterilisation before use | Indicates that the device requires sterilization prior to use. |
| Device labelled as sterile | Indicates the medical device is free from viable microorganisms. See ISO/TS 11139. |
| Containing latex | Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. Choosing "Yes" indicates that the device label or packaging contains one of the following statements: (1) "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions", (2) This Product Contains Dry Natural Rubber", (3) Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" or (4) "The Packaging of This Product Contains Dry Natural Rubber". |
| New Device | Defines if the Device can be considered a 'New' Device or not. A device shall be considered to be ‘new’ if: |
| Not intended to be placed on the EU market | Property defines if the the device is not intended to be placed on the EU market or Not. If submitted with value True, Device is not considered as intended for EU Market. In case the field is submitted with value True, values for fields 'Member State were the Device is placed on the Market' and 'Member state were the device is made available in the market' should not be submitted. |
| Reprocessed single use device | Property defines if the Device is a Reprocessesed single use device or not. |