FDA.reportPublic FDA data

ACCU-CHEK GUIDE LINK

Primary DI
00365702702417
Brand
ACCU-CHEK GUIDE LINK
Company
Roche Diagnostics Operations, Inc.
Model
08109257002
Catalog number
08109257002
Device description
ACCU-CHEK GUIDE LINK MG/DL 118
Published
2023-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OZPAutomated Insulin Dosing Device System, Single Hormonal Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZPAutomated Insulin Dosing Device System, Single Hormonal ControlUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160017110

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160017110MiniMed 670G SystemMedtronic Minimed, Inc.2016-09-28OZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00365702702417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365702702417003657027024173657027024170365702702417

GMDN Terms#

Term, Definition table
TermDefinition
Glucose analyser IVD, home-useAn electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
141608724
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00365702703216ACCU-CHEK GUIDE10439050001 10439050001 2025-03-20
00365702703230ACCU-CHEK GUIDE10439165001 10439165001 2025-03-20
00365702703254ACCU-CHECK GUIDE10439238001 10439238001 2025-03-20
00365702703209 ACCU-CHEK GUIDE10436271001 10436271001 2025-03-20
10365702703213ACCU-CHEK GUIDE10439050001 10439050001 2025-03-20
10365702703237ACCU-CHEK GUIDE10439165001 10439165001 2025-03-20
10365702703251ACCU-CHECK GUIDE10439238001 10439238001 2025-03-20
00365702731103Accu-Chek Guide Me084998960012019-04-08
00365702729100Accu-Chek Guide084530710012018-03-02
00365702702882ACCU-CHEK GUIDE LINK09978330001099783300012023-09-21
10365702702889ACCU-CHEK GUIDE LINK09978330001099783300012023-09-21
00365702702479ACCU-CHEK GUIDE LINK09651926001096519260012023-09-06
00365702702530ACCU-CHEK GUIDE LINK09651942001 09651942001 2023-09-06
10365702702476ACCU-CHEK GUIDE LINK09651926001096519260012023-09-06
10365702702537ACCU-CHEK GUIDE LINK09651942001 09651942001 2023-09-06
00365702724105Accu-Chek Aviva 083500600012018-03-01
00365702702394Accu-Chek Aviva083403310012019-02-28
00365702134102ACCU-CHEK AVIVA PLUS 07021941001070219410012016-08-26
00365702405103ACCU-CHEK AVIVA PLUS06908152001069081520012016-08-26
00365702544109ACCU-CHEK AVIVA068702870012016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150047000MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.OZP2025-11-08
00199150047024MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.OZP2025-11-08
00199150003686MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960018MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960025MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960049MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
20763000956381Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956400Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956417Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956394Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
20763000956404Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
20763000956411Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000960032MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956387Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000926106MiniMed™ 770GMEDTRONIC MINIMED, INC.OZP2024-07-01
00763000926113MiniMed™ 770GMEDTRONIC MINIMED, INC.OZP2024-07-01
00763000924089MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924096MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924102MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924119MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000910082MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-02-03
00763000865665MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2023-10-01
00365702702882ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-21
10365702702889ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-21
00365702702479ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
00365702702530ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
10365702702476ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
10365702702537ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
00763000859206One-press SerterMEDTRONIC MINIMED, INC.OZP2023-08-27
00763000445157Guardian™ Transmitter KitMEDTRONIC MINIMED, INC.OZP2023-05-18