Comfort Soft Plus CO2 Sampling Nasal Cannula

FDA UDI

Class I (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: Pediatric Nasal Cannula, O2/CO2 Sampling Line w/Female Luers, 0.8 Micron Filter FDA UDI
Model / Reference: 0441F FDA UDI
Description: Pediatric Nasal Cannula, O2/CO2 Sampling Line w/Female Luers, 0.8 Micron Filter FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078005633 FDA UDI
FDA Product Code: CAT FDA UDI
CAH FDA UDI
CCK FDA UDI
GMDN Term: Oxygen administration tubing FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5340 FDA UDI
868.5260 FDA UDI
868.1400 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 I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen administration tubing.

STRAIGHT CONNECTOR, DISPOSABLE (ID:22mm, OD:15mm) — BESMED HEALTH BUSINESS CORP. · Class I
PEGASUS — Pegasus Research Corp. · Class I
9362 — Oy Fluorplast Ab · Class IIa
Y-Connector with two 7’ bonded green tubes with ribbed fittings — SALTER LABS · Class IIa
HUDSON RCI — TELEFLEX INCORPORATED · Class I
AirLife™ — VYAIRE MEDICAL, INC. · Class I
Resp-O2 Oxygen Supply Tubing — Dynarex Corp. · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: Westmed, Inc.

Sources (1)

FDA UDI 85de6251-6229-48d9-b5df-6f902c45965c 33 fields · synced May 30, 2026