Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014631252

FEI Number

3014631252

Entity Name

NIHON KOHDEN ORANGEMED, LLC

City/State/Country

Santa Ana, CA, US

Establishment Address

1800 E. Wilshire Avenue, Santa Ana, CA 92705, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nihon Kohden OrangeMed, LLC (Owner Number: 10059216)

Owner / Operator Contact Address

1800 E. Wilshire Avenue, Santa Ana, CA 92705, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181695

PMA Number

N/A

All Registered Proprietary Names

Nihon Kohden NPPV Cap-ONE Mask Set Nihon Kohden Exhalation Port Nihon Kohden NKV-330 Ventilator System Nihon Kohden NKV-550 Series Ventilator System O2 Manifold Nihon Kohden NKV-550 Series Ventilator System Nihon Kohden NKV-550 Series Ventilator System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2022-07-01
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2023-11-07
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2025-12-05
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-12-06
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2018-12-12

Official Correspondent

Sheryl Higgins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nihon Kohden OrangeMed, LLC

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
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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2518422	RESPIRONICS INC.	MURRYSVILLE, PA, US
3010817335	BREAS MEDICAL, INC.	N Billerica, MA, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014631252. Last updated year: 2026. Please use registration number 3014631252 when referencing this establishment in official correspondence.