Nihon Kohden

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden OrangeMed, LLC

Identity

Trade Name: Nihon Kohden FDA UDI
Generic Name: CPAP/BPAP face mask, single-use FDA UDI
Device Name: The NPPV cap-ONE Mask Set (Medium) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient. FDA UDI
Model / Reference: MSK3314P FDA UDI
Description: The NPPV cap-ONE Mask Set (Medium) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient. FDA UDI

Identifiers

Catalog Number: MSK3314P FDA UDI
Primary DI / UDI-DI: 00843685100067 FDA UDI
510(k) Number: K213521 FDA UDI
FDA Product Code: MNT FDA UDI
GMDN Term: CPAP/BPAP face mask, single-use 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: CPAP/BPAP face mask, single-use

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

Similar devices

Also classified as CPAP/BPAP face mask, single-use.

BiTrac Select — Pulmodyne Inc. · Class II
Nebulizing Elbow — Respironics, Inc. · Class II
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
AF541 — Respironics, Inc. · Class II
BiTrac SE Select — Pulmodyne Inc. · Class II
Veraseal 3 Full Face Vented Mask, Small — Sleepnet Corporation · Class II
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Small Adult — Sleepnet Corporation · Class II
AF531 — Respironics, Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nihon Kohden OrangeMed, LLC

Sources (1)

FDA UDI df8facf0-1523-4f9b-898c-3038c46a844f 37 fields · synced Jun 8, 2026