Aerovent Plus®

FDA UDI

Class II (US FDA UDI)

by Monaghan Medical Corp.

Identity

Trade Name: Aerovent Plus® FDA UDI
Generic Name: Medicine chamber spacer, reusable FDA UDI
Model / Reference: CHC, cs/50 FDA UDI

Identifiers

Primary DI / UDI-DI: 00604351858503 FDA UDI
510(k) Number: K110273 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Medicine chamber spacer, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 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: Medicine chamber spacer, reusable

Aerovent Plus® by Monaghan Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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1A CHAMBER — PATEJIM S.R.L. · Class I
OptiChamber Diamond — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
BREATHE COMFORT — Slv Pharmaceuticals LLC · Class II
Vortex — PARI RESPIRATORY EQUIPMENT, INC. · Class II

Cleared under the same submission

K110273 also covers:

Aerovent Plus® — MONAGHAN MEDICAL CORP.

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: Monaghan Medical Corp.

Sources (1)

FDA UDI 830443d1-f149-4617-a6bc-691fbcba9c53 34 fields · synced May 30, 2026