FDA.reportPublic FDA data

Accu-Chek Compact Plus

Primary DI
00365702468108
Brand
Accu-Chek Compact Plus
Company
Roche Diabetes Care GmbH
Model
05888948160
Catalog number
05888948160
Device description
Accu-Chek Compact Plus Clear Control USA
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
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113614000ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics2013-02-12NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10365702468105PackageGS16In Commercial Distribution
00365702468108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1036570246810510365702468105
00365702468108003657024681083657024681080365702468108

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313212471
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04015630088928Accu-Chek Care10095946001100959460012024-11-07
04015630046713Accu-Chek Rapid-D04541103001045411030012016-08-23
04015630048601Accu-Chek Link Assist04530039001045300390012016-08-12
04015630049929Accu-Chek Ultraflex04626583001046265830012016-08-25
04015630049936Accu-Chek Ultraflex04626591001046265910012016-08-25
04015630049943Accu-Chek Ultraflex04626605001046266050012016-08-25
04015630049950Accu-Chek Ultraflex04626613001046266130012016-08-25
04015630049967Accu-Chek Ultraflex04626621001046266210012016-08-25
04015630049974Accu-Chek Ultraflex04626648001046266480012016-08-25
04015630880119Accu-Chek Combo050272500012016-08-25
04015630882755Accu-Chek Spirit Cartridge04949935001049499350012016-08-26
04015630882908Accu-Chek Spirit Cartridge05206073001052060730012016-08-26
04015630883691Accu-Chek Combo05458382001054583820012016-08-25
04015630883806Accu-Chek Combo05458544001054585440012016-08-25
04015630888627Accu-Chek Ultraflex06593976001065939760012016-08-26
04015630888634Accu-Chek Ultraflex06593984001065939840012016-08-26
00075537474198Accu-Chek Compact Plus05599415160055994151602016-08-25
00075537927144Accu-Chek Compact Plus05919983160059199831602016-08-26
00064562213216Accu-Chek Softclix03146693119031466931192023-02-03
00064562213223Accu-Chek Softclix03146707119031467071192023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00021292015381TRUE METRIX PROTRIVIDIA HEALTH, INC.LFR2025-12-02
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
00301939628021CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2025-01-06
00353885012836OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2024-01-31
00850044118250iHealthiHealth Labs Inc.LFR2023-08-30
00850044118267iHealthiHealth Labs Inc.LFR2023-08-30
00850044118205iHealthiHealth Labs Inc.LFR2023-08-24
00353885012799OneTouch Verio FlexLifeScan Europe GmbHLFR2023-05-26
40301939660517CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXTASCENSIA DIABETES CARE US INC.LFR2022-11-23
00353885012102OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012621OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012638OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012645OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012683OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012485OneTouch Verio FlexLifeScan Europe GmbHLFR2022-05-19
00301937828010CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2022-01-07
00301939550018CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-12-08
00301937825019CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-11-22
00353885012423OneTouch VerioLifeScan Europe GmbHLFR2021-09-18
00021292014797TRUE METRIXTRIVIDIA HEALTH, INC.LFR2021-08-06
00301937553011CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2021-07-30
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
00353885012188OneTouch VerioLifeScan Europe GmbHLFR2020-06-30
50096295139551TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-05-11
00357599807009FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00357599808006FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00353885012034OneTouch VerioLifeScan Europe GmbHLFR2020-04-12