Accu-Chek Coaguchek Softclix 07313462001

GUDID 07613336173046

CoaguChek XS Softclix Bulk Black 100 PC

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable
Primary Device ID07613336173046
NIH Device Record Keye9cc5faf-6f65-4659-be2d-c2182054375e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Coaguchek Softclix
Version Model Number07313462001
Catalog Number07313462001
Company DUNS141608724
Company NameRoche Diagnostics Operations, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336173046 [Primary]

FDA Product Code

QRLMultiple Use Blood Lancet For Single Patient Use Only

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-27
Device Publish Date2022-10-19

On-Brand Devices [Accu-Chek Coaguchek Softclix]

07613336173046CoaguChek XS Softclix Bulk Black 100 PC
00365702702240CoaguChek Softclix Lancets USA 10ct
10365702702162CoaguChek XS SC Lancing Device Kit 12/cs
10365702562100CoaguChek Softclix Lancets 25ct 100/cs

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