Aurix Ten Pack Kit

GUDID 10852714003153

Aurix Ten Pack Kit Case of 10 Wound Dressing Kits and 10 Reagent Kits with 010513 Aurix Ten Pack Kit Label

NUO THERAPEUTICS INC

Wound dressing kit, medicated, sterile
Primary Device ID10852714003153
NIH Device Record Keyd3c786b5-6d26-4e11-8643-6342720b04dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurix Ten Pack Kit
Version Model NumberAGWR-04
Company DUNS132418851
Company NameNUO THERAPEUTICS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110852714003153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMQPeripheral Blood Processing Device For Wound Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-11-01
Device Publish Date2016-09-30

Devices Manufactured by NUO THERAPEUTICS INC

10852714003108 - Aurix Wound Dressing Kit2021-11-01 Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02
10852714003122 - Aurix Single Pack Kit2021-11-01 Aurix Single Pack Kit Single Kit with 010405 Aurix Single Pack Kit Label
10852714003139 - Aurix Five Pack Kit2021-11-01 Aurix Five Pack Kit Case of 5 Wound Dressing Kits and 5 Reagent Kits with 010503 Aurix Five Pack Kit Label
10852714003146 - Aurix Eight Pack Kit2021-11-01 Aurix Eight Pack Kit Case of 8 Wound Dressing Kits and 8 Reagent Kits with 010512 Aurix Eight Pack Kit Label
10852714003153 - Aurix Ten Pack Kit2021-11-01Aurix Ten Pack Kit Case of 10 Wound Dressing Kits and 10 Reagent Kits with 010513 Aurix Ten Pack Kit Label
10852714003153 - Aurix Ten Pack Kit2021-11-01 Aurix Ten Pack Kit Case of 10 Wound Dressing Kits and 10 Reagent Kits with 010513 Aurix Ten Pack Kit Label
10852714003016 - Angel Processing Sets (NA)2021-01-08 Angel Processing Sets (NA) Case of 8 Kits or 8 Trays with 020201 Case Label Processing Set (NA)
10852714003023 - Angel Processing Sets (EU)2021-01-08 Angel Processing Sets (EU) Case of 8 Kits or 8 Trays with 016342 Case Label EU Processing Set
00852714003002 - ActivAT2018-03-29 ActivAT Single Unit (Kit or Tray) with 966155001 ActivAT Tray Label

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