Aurix Multifly 4-Pack

GUDID 00852714003194

4-pack of Safety Needles.

Nuo Therapeutics, Inc.

Blood collection set, invasive

• Primary Device ID: 00852714003194
• NIH Device Record Key: c295119b-53db-4911-bb3d-30f77c8b508d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurix Multifly 4-Pack
• Version Model Number: AUXP-001
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852714003194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032150

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: 2023-04-04
• Device Publish Date: 2023-03-27

Devices Manufactured by Nuo Therapeutics, Inc.

• 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: 2023-04-044-pack of Safety Needles.
• 00852714003194 - Aurix Multifly 4-Pack: 2023-04-04 4-pack of Safety Needles.