Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011680766

FEI Number

3011680766

Entity Name

NOVEX INNOVATIONS, LLC

City/State/Country

Winston Salem, NC, US

Establishment Address

101 N CHESTNUT ST STE 308, Winston Salem, NC 27101, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Novex Innovations (Owner Number: 10049549)

Owner / Operator Contact Address

101 N Chestnut Street, Suite 308, Winston Salem, NC 27101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Solution Warming System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2018-11-22
LHC	Warmer, Irrigation Solution	Physical Medicine	Class 1	890.5950	2019-02-01
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-11-22
IMF	Unit, Chilling	Physical Medicine	Class 1	890.5940	2021-12-09

Official Correspondent

Brandi Shanahan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Novex Innovations

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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

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3012466243	JIANGSU YISHUN MEDICAL EQUIPMENT CO., LTD	Nantong Jiangsu, CN
3005951403	AID UNITED INTERNATIONAL CO., LIMITED	SHANGHAI, CN
3036779619	Nureca Technologies Private Limited	Mohali Punjab, IN
9613910	NARANG MEDICAL, LTD.	New Delhi, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011680766. Last updated year: 2026. Please use registration number 3011680766 when referencing this establishment in official correspondence.