FDA.reportPublic FDA data

Accu-Chek Care

Primary DI
04015630088928
Brand
Accu-Chek Care
Company
Roche Diabetes Care GmbH
Model
10095946001
Catalog number
10095946001
Device description
Accu-Chek Care (HCP)
Published
2024-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JQPCalculator/Data Processing Module, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630088928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630088928040156300889284015630088928

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment clinical data interfacing softwareAn application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313212471
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00064562213261Accu-Chek Safe-T-Pro03740838001037408380012023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04
00810142373524SoftPathDxSCC SOFT COMPUTERJQP2026-02-04