FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380068560
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH3050-8
Catalog number
CH3050-8
Device description
ECONOMY URINALYSIS SYSTEM PACK 500
Published
2019-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JXAKIT, SCREENING, URINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXAKit, Screening, UrineMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380068568PackageGS11Not in Commercial Distribution
10885380068560PrimaryGS10
70885380068562Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538006856850885380068568
1088538006856010885380068560
7088538006856270885380068562

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
500
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290006418111DIASLIDE URINE CULTURING DEVICESAVYON DIAGNOSTICS LTDJXA2026-05-04
07290013348531URISCREEN SAVYON DIAGNOSTICS LTDJXA2026-04-29
50885380070271CARDINAL HEALTHCardinal Health 200, LLCJXA2024-02-28
00860008737359Know Rapid STD TestMobiLab Medical Innovatives Inc.JXA2024-02-06
00860008737304MobiLab Standard Sexual Health Self Rapid TestMobiLab Medical Innovatives Inc.JXA2024-02-05
00613647003596FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003602FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003619FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003626FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003633FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003640FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003657FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003664FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003701FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003718FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003590FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003606FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003613FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003620FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003637FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003644FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003651FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003668FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003695FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003705FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003712FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
03573026600389CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19
03573026600402CHROMID® CPS® Elite Agar (CPSO)BIOMERIEUX SAJXA2020-05-19
03573026600426CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep bloodBIOMERIEUX SAJXA2020-05-19
03573026443900CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19