Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1039215

FEI Number

1039215

Entity Name

NIDEK MEDICAL PRODUCTS, INC.

City/State/Country

Birmingham, AL, US

Establishment Address

3949 VALLEY EAST INDUSTRIAL DR, Birmingham, AL 35217, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NIDEK MEDICAL PRODUCTS, INC. (Owner Number: 1039215)

Owner / Operator Contact Address

3949 VALLEY EAST INDUSTRIAL DR, --, Birmingham, AL 35217, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123738

PMA Number

N/A

All Registered Proprietary Names

Multi Flow (Freestanding) Dual Flow (Remote Mounting) Pulmo-Mist Compressor Mark 5 Nuvo 8 OCSI (585, 985) Mark 5 Nuvo 10 OCSI (595, 1005) GCE Mediline Nuvo 8 (985GC, 985GCUK) Mark 5 Nuvo 8 STD (580, 980) Mark 5 Nuvo (505, 565, 905, 965) New Aera Source 5 (565NA) Nuvo Nano Portable Oxygen Concentrator GCE Mediline Nuvo Lite (925GC) Mark 5 Nuvo Lite OCSI (525, 925) Mark 5 Nuvo Lite STD (520, 920) Mark 5 Nuvo Lite 3 (935)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2018-05-17
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2007-11-12
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-11-12
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2010-03-08
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2020-05-08
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2015-10-27

Official Correspondent

Olivia Mullen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NIDEK MEDICAL PRODUCTS, 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
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.

Similar Registrations

Registration Number	Establishment Name	Location
1530881	TRI-TECH MEDICAL, INC.	AVON, OH, US
3022106572	NANTONG KANGJINCHEN MEDICAL EQUIPMENT CO., LTD.	Nantong Jiangsu, CN
3010008150	UNIVAC PRECISION PLASTICS (SUZHOU) CO.,LTD	Suzhou Jiangsu, CN
3043607924	AKTIV TECHNOLOGIES PVT LTD	Faridabad Haryana, IN
3013156250	DEHAS Medical Systems GmbH	Luebeck Schleswig-Holstein, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1039215. Last updated year: 2026. Please use registration number 1039215 when referencing this establishment in official correspondence.