Comfort Soft Plus CO2 Sampling Nasal Cannula

FDA UDI

Class II (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Comfort Soft Plus CO2 Sampling Nasal Cannula FDA UDI
Generic Name: Oxygen administration tubing FDA UDI
Device Name: Adult nasal Cannula, 10' O2/CO2 Sampling Line w/male Luer FDA UDI
Model / Reference: 0538 FDA UDI
Description: Adult nasal Cannula, 10' O2/CO2 Sampling Line w/male Luer FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078001413 FDA UDI
FDA Product Code: CCK FDA UDI
CAT FDA UDI
GMDN Term: Oxygen administration tubing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 FDA UDI
868.5340 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Nasal oxygen cannula, carbon-dioxide-sampling Oxygen administration tubing

Comfort Soft Plus CO2 Sampling Nasal Cannula by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Westmed, Inc.

Sources (1)

FDA UDI f9764d69-37c9-44fb-9df8-07ab46b98de6 33 fields · synced May 30, 2026