Accu-Chek Guide Link

GUDID 10365702738109

ACCU-CHEK GUIDE LINK REPLACEMENT KIT US

Roche Diagnostics Operations, Inc.

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Primary Device ID10365702738109
NIH Device Record Key763243d7-eaf7-4c29-8c86-cdab741bb794
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Guide Link
Version Model Number09015728001
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 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
GS100365702738102 [Primary]
GS110365702738109 [Package]
Contains: 00365702738102
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 Date2020-11-09
Device Publish Date2020-10-30

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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