FDA.reportPublic FDA data

Centrio

Primary DI
00852714003354
Brand
Centrio
Company
Nuo Therapeutics, Inc.
Model
Centrio PRP 2 Tubes
Device description
2Tube Phlebotomy Kit suitable for use with Centrio PRP System
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00852714003354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852714003354008527140033548527140033540852714003354

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.

Regulatory Flags#

DUNS number
118447207
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852714003361CentrioCentrio PRP 4 Tubes2026-06-02
008527140032484TRAUXP-4TR2024-03-21
00852714003194Aurix Multifly 4-PackAUXP-0012023-03-27
10852714003108Aurix Wound Dressing KitAGSW-022016-09-30
10852714003122Aurix Single Pack KitAUSP-012016-09-30
10852714003139Aurix Five Pack KitAUSP-052016-09-30
10852714003146Aurix Eight Pack KitAUSP-082016-09-30
10852714003153Aurix Ten Pack KitAGWR-042016-09-30
00852714003095Aurix CentrifugeAGSC-042016-09-30
00852714003101Aurix Wound Dressing KitAGSW-022016-09-30
00852714003118Aurix Reagent KitAGSR-032016-09-30
00852714003224Aurix XL PlusAUXP-4T2025-10-06
00852714003279CentrioCentrio PRP System- Single Kit2025-09-01
00852714003286CentrioCentrio PRP System - 5 Kits2025-09-01
00852714003293CentrioCentrio PRP System - 10 Kits2025-09-01
00852714003309CentrioCentrio PRP System - Office Single Kit2025-09-01
00852714003316CentrioCentrio Multifly Needle - 4 Pack2025-09-01
00852714003323CentrioWound Dressing Kit2025-09-01
00852714003330CentrioReagent Kit2025-09-01
00852714003347CentrioOffice Wound Dressing Kit2025-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00852714003187Aurix XLNuo Therapeutics, Inc.OFM2023-03-27