Accu-Chek Safe-T-Pro 03450074001

GUDID 00365702702196

Accu-Chek Safe-T-Pro Plus 5ct

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable
Primary Device ID00365702702196
NIH Device Record Key4ee0ca35-c853-437c-bb9b-5173bd629d13
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Safe-T-Pro
Version Model Number03450074001
Catalog Number03450074001
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
GS100365702702196 [Primary]

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 Date2022-10-27
Device Publish Date2022-10-19

On-Brand Devices [Accu-Chek Safe-T-Pro]

00365702702196Accu-Chek Safe-T-Pro Plus 5ct
10365702702148Accu-Chek Safte-T-Pro Plus 200ct Coag 6/cs
00365702700475Accu-Chek Safe-T-Pro Uno 10ct
10365702700465Accu-Chek Safe-T-Pro Uno 200ct 16/cs
10075537257897Accu-Chek Safe-T-Pro Plus 200ct

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