Nihon Kohden

Basic Information

• Brand Name: Nihon Kohden
• Primary DI: 00843685100012
• Version / Model: NKV-550-U
• Catalog Number: NKV-550-U
• Company Name: NIHON KOHDEN ORANGEMED, INC.
• Labeler DUNS: 079962037
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-02
• Public Version: 3
• Public Version Date: 2023-06-06
• Public Version Status: Update
• Public Device Record Key: e26498dc-74f2-4532-8e77-f886919fc279

Device Description

The Nihon Kohden NKV-550-U is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for neonatal through adult patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42411	Neonatal/adult intensive-care ventilator	A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843685100012	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181695	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Altitude: 6096 meters (maximum)
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius