ACCU-CHEK GUIDE LINK 09651942001

GUDID 10365702702537

Accu-Chek Guide Link MO Replacement US

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, spectrophotometry
Primary Device ID10365702702537
NIH Device Record Key7b502ff8-49b5-4c23-b10b-4c2f3b1302f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCU-CHEK GUIDE LINK
Version Model Number09651942001
Catalog Number09651942001
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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
GS100365702702530 [Primary]
GS110365702702537 [Package]
Contains: 00365702702530
Package: [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZPAutomated Insulin Dosing Device System, Single Hormonal Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-14
Device Publish Date2023-09-06

On-Brand Devices [ACCU-CHEK GUIDE LINK]

10365702738109ACCU-CHEK GUIDE LINK REPLACEMENT KIT US
10365702702292ACCU-CHEK GUIDE LINK FC US MG/DL
00365702702134ACCU-CHEK GUIDE LINK MG/DL 118 (US)
10365702702537Accu-Chek Guide Link MO Replacement US
10365702702476Accu-Chek Guide Link SC mg/dL
10365702702889ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US
00365702702417ACCU-CHEK GUIDE LINK MG/DL 118

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