Accu-Chek Softclix 03144844001

GUDID 04015630084937

Accu-Chek Softclix Lancets 10/pk

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable
Primary Device ID04015630084937
NIH Device Record Key0b407ee6-dac9-40ca-a9da-1a8deeb02be3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Softclix
Version Model Number03144844001
Catalog Number03144844001
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 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
GS104015630084937 [Primary]

FDA Product Code

QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-05
Device Publish Date2022-09-27

On-Brand Devices [Accu-Chek Softclix]

04015630084937Accu-Chek Softclix Lancets 10/pk
04015630082209Accu-Chek Softclix Black Bulk 100
00365702897106Accu-Chek Softclix Mailorder 100ct 12/cs
00365702700123Accu-Chek Softclix AST Kit USA
00365702400108Accu-Chek Softclix (black) USA 12/case
00365702156104Accu-Chek Softclix HN Lancets 100ct 12cs
00075537009710Accu-Chek Softclix Lancets 100ct 12/cs
10365702702827Accu-Chek Softclix Kit Canada

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