FDA.reportPublic FDA data

ACCU-CHEK AVIVA EXPERT

Primary DI
00365702575103
Brand
ACCU-CHEK AVIVA EXPERT
Company
Roche Diagnostics Operations, Inc.
Model
06699430001
Catalog number
06699430001
Device description
ACCU-CHEK AVIVA EXPERT KIT US
Published
2016-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00365702575103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365702575103003657025751033657025751030365702575103

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
141608724
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
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
00365702702417ACCU-CHEK GUIDE LINK08109257002081092570022023-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19