FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380173127
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH2440058
Catalog number
CH2440058
Device description
Beta-Hydroxybutyrate Liquicolor
Published
2019-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JINNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380173127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538017312710885380173127

GMDN Terms#

Term, Definition table
TermDefinition
Beta-hydroxybutyrate IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) in a clinical specimen, using an enzyme spectrophotometry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.25Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956537798CARDINAL HEALTHSOP53TOWRGSOP53TOWRG2026-10-13
10198956539914CARDINAL HEALTHSOP48EX85ASOP48EX85A2026-10-13
10198956541658CARDINAL HEALTHSAN1DRPUNCSAN1DRPUNC2026-10-13
10198956545182CARDINAL HEALTHSOP53SLVLLSOP53SLVLL2026-10-13
10198956549050CARDINAL HEALTHSOP45THBMJSOP45THBMJ2026-10-13
10198956559516CARDINAL HEALTH08-0857C08-0857C2026-10-13
10198956562950CARDINAL HEALTHSBA43MPMADSBA43MPMAD2026-10-13
10198956563223CARDINAL HEALTHSOP42ARBTHSOP42ARBTH2026-10-13
10198956564237CARDINAL HEALTHSEY45BPPAESEY45BPPAE2026-10-13
10198956570740CARDINAL HEALTHSEN48ESSNASEN48ESSNA2026-10-13
10198956570993CARDINAL HEALTH34-2403F34-2403F2026-10-13
10198956573024CARDINAL HEALTHSMA54MGFMPSMA54MGFMP2026-10-13
10198956577084CARDINAL HEALTH08-0857D08-0857D2026-10-13
10198956578753CARDINAL HEALTH34-7753A34-7753A2026-10-13
10198956588721CARDINAL HEALTHSMA40DERWDSMA40DERWD2026-10-13
10198956589810CARDINAL HEALTHSBAOCRPS30SBAOCRPS302026-10-13
10198956592698CARDINAL HEALTHSAN53ANOV6SAN53ANOV62026-10-13
10198956593770CARDINAL HEALTHSOTOCURGR3SOTOCURGR32026-10-13
10198956595071CARDINAL HEALTH31-826AW31-826AW2026-10-13
10198956597891CARDINAL HEALTHSBA43RPUSESBA43RPUSE2026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.JIN2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.JIN2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.JIN2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.JIN2026-07-30
00860015091604KetoBMKETOBM USA LLCJIN2026-07-14
00860015091628KetoBMKETOBM USA LLCJIN2026-07-14
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18