FDA.reportPublic FDA data

Aurix Centrifuge

Primary DI
00852714003095
Brand
Aurix Centrifuge
Company
Nuo Therapeutics, Inc.
Model
AGSC-04
Device description
Aurix Centrifuge with 010463 Aurix Centrifuge Machine Registration Label
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PMQPeripheral Blood Processing Device For Wound Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMQPeripheral Blood Processing Device For Wound ManagementHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0600070

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0600070

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852714003095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852714003095008527140030958527140030950852714003095

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose tabletop centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to separate the components of suspensions through low- or medium-speed centrifugal force (typically up to 6,000 or 12,000 rpm). It is typically a compact stationary structure with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. This device is mostly used to centrifuge various patient samples (i.e., body fluids), either alone or after addition of reagents or other additives before measuring analytes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118447207
Device count
1
Serial number
true
Manufacturing date on label
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
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
00852714003187Aurix XLAUXP-2T2023-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033131192Cellular MembraneRegenlab USA LLCPMQ2025-12-04
00850033131178RegenKit-ATS-T-URegenlab USA LLCPMQ2025-10-31
00850033131185RegenKit-ATS-3-URegenlab USA LLCPMQ2025-10-31
00850047730305Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00852714003279CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003286CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003293CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003309CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003323CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003330CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003347CentrioNuo Therapeutics, Inc.PMQ2025-09-01
10860000244319ActiGraftREDDRESS LTDPMQ2025-03-23
00860000244312ActiGraftREDDRESS LTDPMQ2025-03-23
008527140032484TRNuo Therapeutics, Inc.PMQ2024-03-21
00850033131093RegenKit Wound-GelRegenlab USA LLCPMQ2024-03-12
00850047730008Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730015Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730022Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730039Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730046Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730053Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730060Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730077Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
07640138981616RegenPlasma/RegenKit-Woud Gel-2REGEN LAB SAPMQ2023-01-19
057141883018083CP™ CounterbalanceReapplix ApSPMQ2019-05-23
057141883080053CP™ Centrifuge KitReapplix ApSPMQ2019-05-23