FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956207637
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
07-4432B
Catalog number
07-4432B
Device description
CENTRAL LINE BLOOD DRAW KIT
Published
2025-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50198956207637PackageGS140In Commercial Distribution
10198956207639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895620763750198956207637
1019895620763910198956207639

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

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
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
00852714003187Aurix XLNuo Therapeutics, Inc.OFM2023-03-27