FDA.reportPublic FDA data

ACCU-CHEK NANO

Primary DI
00365702637108
Brand
ACCU-CHEK NANO
Company
Roche Diagnostics Operations, Inc.
Model
05423066001
Device description
ACCU-CHEK NANO MTR MG/DL (596)
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
00365702637108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365702637108003657026371083657026371080365702637108

GMDN Terms#

Term, Definition table
TermDefinition
Home-use/point-of-care glucose analyser IVD, battery-poweredAn exclusively battery-powered instrument intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the quantitative in vitro measurement of glucose levels in whole blood. 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
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
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON BIORESEARCH INC.NBW2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563841Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08