Nihon Kohden

Basic Information

• Brand Name: Nihon Kohden
• Primary DI: 00843685100043
• Version / Model: NKV-330
• Catalog Number: NKV-330
• Company Name: NIHON KOHDEN ORANGEMED, INC.
• Labeler DUNS: 079962037
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-18
• Public Version: 1
• Public Version Date: 2022-07-26
• Public Version Status: New
• Public Device Record Key: 994bc6aa-8cc6-4fd8-b33e-5bb71c1b89f9

Device Description

The Nihon Kohden NKV-330 Ventilator is an assist ventilator intended to support adult and pediatric patients who are breathing spontaneously and require a tidal volume of 100mL or more with an oxygen concentration of 21 to 100%. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications.

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
MNT	Ventilator, Continuous, Minimal Ventilatory Support, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47083	Portable electric ventilator	A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843685100043	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K213521	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 65 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Altitude: between -1250 and 9878 feet above sea level
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal