Aurix Reagent Kit

Basic Information

• Brand Name: Aurix Reagent Kit
• Primary DI: 00852714003118
• Version / Model: AGSR-03
• Company Name: Nuo Therapeutics, Inc.
• Labeler DUNS: 118447207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 6b39e1ed-e123-419a-915e-ede8c40fffc4

Device Description

Aurix Reagent Kit Single Kit with 010110 Reagent Kit Label

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
PMQ	Peripheral Blood Processing Device For Wound Management	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34059	Wound dressing kit, medicated	A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852714003118	GS1

Premarket Submissions

Submission Number	Supplement Number
BK060007	0