FDA.reportPublic FDA data

Aurix

Primary DI
00852714003224
Brand
Aurix
Company
Nuo Therapeutics, Inc.
Model
XL Plus
Catalog number
AUXP-4T
Device description
Phlebotomy kit (4 tubes)
Published
2025-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00852714003224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852714003224008527140032248527140032240852714003224

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
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00852714003187Aurix XLAUXP-2T2023-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00852937003025INNOVATE MEDICALINNOVATE MEDICAL, LLCOFM2022-11-14
00852937003018INNOVATE MEDICALINNOVATE MEDICAL, LLCOFM2022-11-14