ACCU-CHECK GUIDE 10439238001

GUDID 10365702703251

ACCU-CHEK GUIDE CASH US 60CT STRIP

Roche Diagnostics Operations, Inc.

Glucose IVD, reagent
Primary Device ID10365702703251
NIH Device Record Key5c199778-f4de-4253-999a-1d8d6d8553a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCU-CHECK GUIDE
Version Model Number10439238001
Catalog Number10439238001
Company DUNS141608724
Company NameRoche Diagnostics Operations, Inc.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100365702703254 [Primary]
GS110365702703251 [Package]
Contains: 00365702703254
Package: [24 Units]
In Commercial Distribution
GS150365702703259 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

Devices Manufactured by Roche Diagnostics Operations, Inc.

00365702703209 - ACCU-CHEK GUIDE2025-03-28 VIAL LBLD 30CT STRIP ACCU-CHEK GUIDE
10365702703213 - ACCU-CHEK GUIDE2025-03-28 ACCU-CHEK GUIDE CASH VALUE KIT
10365702703237 - ACCU-CHEK GUIDE2025-03-28 ACCU-CHEK GUIDE CASH US 30CT STRIP
10365702703251 - ACCU-CHECK GUIDE2025-03-28ACCU-CHEK GUIDE CASH US 60CT STRIP
10365702703251 - ACCU-CHECK GUIDE2025-03-28 ACCU-CHEK GUIDE CASH US 60CT STRIP
00365702702417 - ACCU-CHEK GUIDE LINK2023-09-29 ACCU-CHEK GUIDE LINK MG/DL 118
10365702702889 - ACCU-CHEK GUIDE LINK2023-09-29 ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US
10365702702476 - ACCU-CHEK GUIDE LINK2023-09-14 Accu-Chek Guide Link SC mg/dL
10365702702537 - ACCU-CHEK GUIDE LINK2023-09-14 Accu-Chek Guide Link MO Replacement US

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