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Unique Device Identification (UDI)
Transcript of Unique Device Identification (UDI)
UDI is “a unique number pertaining to a medical device that enables the identification of different types of devices and the access to useful and relevant information stored in a UDI database".
UDI can make:
- Traceability of devices more efficient
- Allow easier recall of devices
- Fight against counterfeiting and improve patient safety.
UDI is provided in two forms:
1) Easily-readable plain text (alphanumeric or numeric).
2)AIDC (Automatic Identification and Data Capture)
- Any type of bar code
- RFID (Radio Frequency Identification)
- Near-field communication (e.g. Touching Smart Phones).
According to the UDI final rule the label of a medical device include a:
- Bar code
- Printed expiration date
- Date of manufacture
The date must be presented in the following format: the year, followed by the month, followed by the day.
NovaSure Devices UDI
Unique Device Identification System (UDI)
For more information...
Further information for UDI Final Rule Costa Rica site implementation:
Irene Barquero / Project Sponsor.
Felipe Pérez / Project Leader.
ENG-0034-39 Device Identifier Work Instruction
ADM-0505 Device Identifier
U.S Food and Drug Administration
UDI = DI + PI
Purpose of UDI:
Identification of a device and key attributes that affect its safe and effective use.
More accurate reporting of adverse events, identification of associated device, and enhanced corrective actions.
- Static identifier of specific version or model and manufacturer (labeler).
- Dynamic identifier of one or more of the following when included on the label:
- The lot / batch within which a device was manufactured.
- The serial number of a specific device.
- The expiration date of a specific device.
- The date a specific device was manufactured.
The UDI identification includes the following:
Global Unique Device Identification Database
GUDID is a publicly database administered by the FDA that will serve as a reference catalog for every device with an identifier.
The GUDID serves as the repository of key device identification information.
The GUDID contains ONLY the DI, which serves as the primary key to obtain device information in the database.
1) International (not-for-profit) association with Member Organizations in over 100 countries.
2) Official provider of bar codes numbers
Mandated by the FDA and the EU Commission
Class III. Sept 24, 2014
* Label must bear a UDI
* Device must be submitted to GUDID database (Global Unique Device Identifier Database
Class II. Sept 24, 2016
Class I. Sept 24, 2018