Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004140833

FEI Number

3004140833

Entity Name

NUO THERAPEUTICS, INC.

City/State/Country

Houston, TX, US

Establishment Address

8285 El Rio, Suite 190, Houston, TX 77054, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Nuo Therapeutics, Inc. (Owner Number: 9058053)

Owner / Operator Contact Address

8285 El Rio, Suite 190, Houston, TX 77054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032150

PMA Number

N/A

All Registered Proprietary Names

Aurix XL Aurix 4TR Aurix Multifly 4-Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OFM	Phlebotomy Blood Collection Kit	Cardiovascular	Class 2	870.2750	2023-03-23
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2007-11-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-03-27
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-03-27

Official Correspondent

Peter Clausen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nuo Therapeutics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3009888344	Isomedix Operations Inc	El Paso, TX, US
1825034	BIOMET, INC.	WARSAW, IN, US
2321034	INNOVATE MEDICAL, LLC	Johnson City, TN, US
1123010	TRINITY STERILE, INC.	SALISBURY, MD, US
3013175547	PRINTCRAFT PRESS	Idaho Falls, ID, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004140833. Last updated year: 2026. Please use registration number 3004140833 when referencing this establishment in official correspondence.