Adult CO2 /O2 Mask

FDA UDI

Class II (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Adult CO2 /O2 Mask FDA UDI
Generic Name: Oxygen administration tubing FDA UDI
Device Name: Adult CO2/O2 Mask, 10'x 0.50 GLS w Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter FDA UDI
Model / Reference: 0562F FDA UDI
Description: Adult CO2/O2 Mask, 10'x 0.50 GLS w Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078005664 FDA UDI
FDA Product Code: CCK FDA UDI
CAH FDA UDI
GMDN Term: Oxygen administration tubing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 FDA UDI
868.5260 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

Adult CO2 /O2 Mask by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Resp-O2 Oxygen Supply Tubing — Dynarex Corp. · Class I
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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 c447e4d5-3b0a-4e54-a424-584f8e07b04f 33 fields · synced Jun 6, 2026