Nihon Kohden

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden OrangeMed, LLC

Identity

Trade Name: Nihon Kohden FDA UDI
Generic Name: Portable electric ventilator FDA UDI
Device Name: 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. FDA UDI
Model / Reference: NKV-330 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: NKV-330 FDA UDI
Primary DI / UDI-DI: 00843685100043 FDA UDI
510(k) Number: K213521 FDA UDI
FDA Product Code: MNT FDA UDI
GMDN Term: Portable electric ventilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Portable electric ventilator

Nihon Kohden by Nihon Kohden OrangeMed, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K213521 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Nihon Kohden OrangeMed, LLC

Sources (1)

FDA UDI 994bc6aa-8cc6-4fd8-b33e-5bb71c1b89f9 37 fields · synced Jun 8, 2026