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Comfort Soft Plus CO2/O2 Mask

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name
Comfort Soft Plus CO2/O2 Mask FDA UDI
Generic Name
Straight/elbow breathing circuit connector, single-use FDA UDI
Device Name
adult CO2/O2 Mask, 10' x 0.050 GSL w swivel elbow, 2" Pigtail w/ female luer connectors, 7' oxygen supply tubing FDA UDI
Model / Reference
0562 FDA UDI
Description
adult CO2/O2 Mask, 10' x 0.050 GSL w swivel elbow, 2" Pigtail w/ female luer connectors, 7' oxygen supply tubing FDA UDI

Identifiers

Primary DI / UDI-DI
00709078001697 FDA UDI
FDA Product Code
CAT FDA UDI
CAI FDA UDI
GMDN Term
Straight/elbow breathing circuit connector, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5340 FDA UDI
868.5240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nasal oxygen cannula, carbon-dioxide-samplingStraight/elbow breathing circuit connector, single-use

Comfort Soft Plus CO2/O2 Mask by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Straight/elbow breathing circuit connector, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Westmed, Inc.

Sources (1)

  • FDA UDI 0d275a79-1fab-4349-94f0-5558fe6725f0 33 fields · synced Jun 8, 2026