Accu-Chek Coaguchek Softclix 06979009001

GUDID 10365702562100

CoaguChek Softclix Lancets 25ct 100/cs

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 ID10365702562100
NIH Device Record Keyf043a230-fe27-49ba-8094-7e583d67e408
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Coaguchek Softclix
Version Model Number06979009001
Catalog Number06979009001
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100365702562103 [Primary]
GS110365702562100 [Package]
Contains: 00365702562103
Package: [100 Units]
In Commercial Distribution

FDA Product Code

QRLMultiple Use Blood Lancet For Single Patient Use Only

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.