Accu-Chek Safe-T-Pro 03740838001

GUDID 10064562213268

Accu-Chek Safe-T-Pro Plus (CDN, US)

Roche Diabetes Care GmbH

Manual blood lancing device, reusable
Primary Device ID10064562213268
NIH Device Record Keycc211ba9-193c-4fc0-a091-5fce7bf5337a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Safe-T-Pro
Version Model Number03740838001
Catalog Number03740838001
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 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
GS100064562213261 [Primary]
GS110064562213268 [Package]
Contains: 00064562213261
Package: [6 Units]
In Commercial Distribution

FDA Product Code

FMKSingle Use Only Blood Lancet With 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

Devices Manufactured by Roche Diabetes Care GmbH

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04015630049929 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 8/60 10pcs
04015630049936 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 8/80 10pcs
04015630049943 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 8/110 10pcs
04015630049950 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 10/60 10pcs
04015630049967 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 10/80 10pcs

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