Circulaire II Aerosol Delivery System

FDA UDI

Class II (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Circulaire II Aerosol Delivery System FDA UDI
Generic Name: Nebulizing system delivery set, single-use FDA UDI
Device Name: with Adult non-vented mask, mouthpiece, B/V filter FDA UDI
Model / Reference: 0332 FDA UDI
Description: with Adult non-vented mask, mouthpiece, B/V filter FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078000768 FDA UDI
FDA Product Code: CAF FDA UDI
CAH FDA UDI
GMDN Term: Nebulizing system delivery set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 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

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Manufacturing Date

FDA UDI

Category: Heat/moisture exchanger/microbial medical gas filter Nebulizing system delivery set, single-use Aerosol face mask, rebreathing, single-use

Circulaire II Aerosol Delivery System 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 b3f48cd7-a40d-4225-9432-53c91a3ca172 33 fields · synced May 30, 2026