Aurix Reagent Kit

GUDID 00852714003118

Aurix Reagent Kit Single Kit with 010110 Reagent Kit Label

NUO THERAPEUTICS INC

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• Primary Device ID: 00852714003118
• NIH Device Record Key: 6b39e1ed-e123-419a-915e-ede8c40fffc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurix Reagent Kit
• Version Model Number: AGSR-03
• Company DUNS: 132418851
• Company Name: NUO THERAPEUTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852714003118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060007

FDA Product Code

• PMQ: Peripheral Blood Processing Device For Wound Management

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-30

Devices Manufactured by NUO THERAPEUTICS INC

• 10852714003108 - Aurix Wound Dressing Kit: 2021-11-01 Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02
• 10852714003122 - Aurix Single Pack Kit: 2021-11-01 Aurix Single Pack Kit Single Kit with 010405 Aurix Single Pack Kit Label
• 10852714003139 - Aurix Five Pack Kit: 2021-11-01 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 Kit: 2021-11-01 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 Kit: 2021-11-01 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 - ActivAT: 2018-03-29 ActivAT Single Unit (Kit or Tray) with 966155001 ActivAT Tray Label