4TR

GUDID 00852714003248

Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit

Nuo Therapeutics, Inc.

Wound dressing kit, medicated

• Primary Device ID: 00852714003248
• NIH Device Record Key: 144af523-0f43-4c60-ae46-9ba663bdfe8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4TR
• Version Model Number: AUXP-4TR
• Company DUNS: 118447207
• 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: false
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852714003248 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-29
• Device Publish Date: 2024-03-21

Devices Manufactured by Nuo Therapeutics, Inc.

• 00852714003248 - 4TR: 2024-03-29Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit
• 00852714003248 - 4TR: 2024-03-29 Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit
• 00852714003187 - Aurix XL: 2023-04-04 Aurix XL is a phlebotomy convenience kit
• 00852714003194 - Aurix Multifly 4-Pack: 2023-04-04 4-pack of Safety Needles.