Aurix XL

Basic Information

• Brand Name: Aurix XL
• Primary DI: 00852714003187
• Version / Model: AUXP-2T
• Company Name: Nuo Therapeutics, Inc.
• Labeler DUNS: 118447207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-27
• Public Version: 1
• Public Version Date: 2023-04-04
• Public Version Status: New
• Public Device Record Key: 8f122966-1f65-48af-b14b-1961ecb31ad9

Device Description

Aurix XL is a phlebotomy convenience kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFM	Phlebotomy Blood Collection Kit	Cardiovascular	870.2750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18026	Phlebotomy kit	A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852714003187	GS1