FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594383893
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SVA15PHFHB
Catalog number
SVA15PHFHB
Device description
PHLEBECTOMY PACK
Published
2021-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFMPhlebotomy blood collection kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFMPhlebotomy Blood Collection KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594383891PackageGS13In Commercial Distribution
10195594383893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559438389150195594383891
1019559438389310195594383893

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852714003354CentrioNuo Therapeutics, Inc.OFM2026-06-02
00852714003361CentrioNuo Therapeutics, Inc.OFM2026-06-02
10198956292130CARDINAL HEALTHCardinal Health 200, LLCOFM2026-02-12
10198956234901CARDINAL HEALTHCardinal Health 200, LLCOFM2026-01-15
50198956234909CARDINAL HEALTHCardinal Health 200, LLCOFM2026-01-15
10809160505342Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-12-02
20809160505349Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-12-02
10809160501276Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-10-30
00852714003224Aurix Nuo Therapeutics, Inc.OFM2025-10-06
10198956207639CARDINAL HEALTHCardinal Health 200, LLCOFM2025-09-29
50198956207637CARDINAL HEALTHCardinal Health 200, LLCOFM2025-09-29
10198956062696CARDINAL HEALTHCardinal Health 200, LLCOFM2025-05-29
50198956062694CARDINAL HEALTHCardinal Health 200, LLCOFM2025-05-29
10809160466605Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-05-08
20809160466602Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-05-08
10809160460719Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-18
20809160460716Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-18
10809160460207Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-12
20809160460204Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-12
00860009842274Straight Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
00860009842281Butterfly Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
10809160432501Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-08-16
20809160432508Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-08-16
10809160424421Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-04-30
20809160424428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-04-30
10194717117827Regard™ROI CPS, LLCOFM2023-09-29
20194717117824Regard™ROI CPS, LLCOFM2023-09-29
20194717117831Regard™ROI CPS, LLCOFM2023-09-29
10809160403327Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2023-06-23
20809160403324Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2023-06-23