Accu-Chek Softclix 03146693119

GUDID 10064562213213

Accu-Chek Softclix Lancet 200 (CND, US)

Roche Diabetes Care GmbH

Manual blood lancing device, reusable
Primary Device ID10064562213213
NIH Device Record Key76373241-ae26-472c-8b4b-1f7e042f53dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Softclix
Version Model Number03146693119
Catalog Number03146693119
Company DUNS313212471
Company NameRoche Diabetes Care GmbH
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
GS100064562213216 [Primary]
GS110064562213213 [Package]
Contains: 00064562213216
Package: [6 Units]
In Commercial Distribution

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 Date2023-02-13
Device Publish Date2023-02-03

On-Brand Devices [Accu-Chek Softclix]

10064562213220Accu-Chek Softclix Lancet 100 (CND, US)
10064562213213Accu-Chek Softclix Lancet 200 (CND, US)

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