Accu-Chek Guide Link

GUDID 10365702702292

ACCU-CHEK GUIDE LINK FC US MG/DL

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry
Primary Device ID10365702702292
NIH Device Record Key390c82d5-a922-4b4f-97a7-f009869ee714
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Guide Link
Version Model Number08116083022
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
GS100365702702295 [Primary]
GS100365702702295 [Primary]
GS100365702702295 [Primary]
GS100365702702295 [Primary]
GS100365702702295 [Primary]
GS100365702702295 [Primary]
GS100365702702295 [Primary]
GS100365702702295 [Primary]
GS110365702702292 [Package]
Contains: 00365702702295
Package: [16 Units]
In Commercial Distribution
GS110365702702292 [Package]
Contains: 00365702702295
Package: [16 Units]
In Commercial Distribution
GS110365702702292 [Package]
Contains: 00365702702295
Package: [16 Units]
In Commercial Distribution
GS110365702702292 [Package]
Contains: 00365702702295
Package: [16 Units]
In Commercial Distribution
GS110365702702292 [Package]
Contains: 00365702702295
Package: [16 Units]
In Commercial Distribution
GS110365702702292 [Package]
Contains: 00365702702295
Package: [16 Units]
In Commercial Distribution
GS110365702702292 [Package]
Contains: 00365702702295
Package: [16 Units]
In Commercial Distribution
GS110365702702292 [Package]
Contains: 00365702702295
Package: [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZPAutomated Insulin Dosing Device System, Single Hormonal Control
OZPAutomated Insulin Dosing Device System, Single Hormonal Control
OZPAutomated Insulin Dosing Device System, Single Hormonal Control
OZPAutomated Insulin Dosing Device System, Single Hormonal Control
OZPAutomated Insulin Dosing Device System, Single Hormonal Control
OZPAutomated Insulin Dosing Device System, Single Hormonal Control
OZPAutomated Insulin Dosing Device System, Single Hormonal Control
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)

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