2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC15
  



  

  
Submitter : 
  

  
Mr. Hemant Jampala
  

  
Date & Time: 
  

  
08/29/2006 11:08:34
  



  

  
Organization : 
  

  
HCL Technologies Ltd.
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 The devices should contain a bar code in a unique format so that the device can be identified uniquely. The Bar code can be a combination of the Company Id (J&J, Baxter etc.), the device category (X-ray machine, Blood Glucose Meter etc.), a model number (Accucheck Active, Accucheck Plus etc.), a list of non-compatible devices, mode of use (Adult, Neo-Natal etc.) and a unique device id (much like the IMEI in cellular phones). If it is not possible to have all the data in a bar code, it could become part of labelling on the device itself (the labelling can be in plain English and can be extended to local languages also, at a later date). 

The classification of the devices can already be picked up from the existing device classification and companies can be asked to register for company codes. This will make the device companies more answerable and the tracking of the devices can be done in a more uniform fashion throughout the world. This will also help the device manufacturing compaines to keep track of their devices more effectively.