Aurix Wound Dressing Kit

GUDID 00852714003101

Aurix Wound Dressing Kit Single Unit (Kit or Tray) with 010364 Tyvek Lidstock Label for AGSW-02

NUO THERAPEUTICS INC

Wound dressing kit, medicated, sterile

• Primary Device ID: 00852714003101
• NIH Device Record Key: 11ad4fb0-f970-4dea-a4d6-74039c4eeb32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurix Wound Dressing Kit
• Version Model Number: AGSW-02
• 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	00852714003101 [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

On-Brand Devices [Aurix Wound Dressing Kit]

• 00852714003101: Aurix Wound Dressing Kit Single Unit (Kit or Tray) with 010364 Tyvek Lidstock Label for AGSW-02
• 10852714003108: Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02