FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594043520
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17-0030B
Catalog number
17-0030B
Device description
BLOOD DRAW KIT
Published
2021-05-03
Public version status
Update
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
50195594043528PackageGS130In Commercial Distribution
10195594043520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559404352850195594043528
1019559404352010195594043520

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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