FDA.reportPublic FDA data

Aurix Multifly 4-Pack

Primary DI
00852714003194
Brand
Aurix Multifly 4-Pack
Company
Nuo Therapeutics, Inc.
Model
AUXP-001
Device description
4-pack of Safety Needles.
Published
2023-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032150000SAFETY-MULTIFLYSarstedt, Inc.2003-09-12FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852714003194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852714003194008527140031948527140031940852714003194

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118447207
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852714003354CentrioCentrio PRP 2 Tubes2026-06-02
00852714003361CentrioCentrio PRP 4 Tubes2026-06-02
008527140032484TRAUXP-4TR2024-03-21
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