Aerochamber®

FDA UDI

Class I (US FDA UDI)

by Monaghan Medical Corp.

Identity

Trade Name: Aerochamber® FDA UDI
Generic Name: Medicine chamber spacer, reusable FDA UDI
Model / Reference: HC MV, cs/10 FDA UDI

Identifiers

Primary DI / UDI-DI: 00604351985100 FDA UDI
510(k) Number: K900557 FDA UDI
FDA Product Code: CCQ FDA UDI
GMDN Term: Medicine chamber spacer, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5640 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

Aerochamber® by Monaghan Medical Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K900557 also covers:

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

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Manufacturer

Manufacturer: Monaghan Medical Corp.

Sources (1)

FDA UDI b62125c0-b78b-49db-9bce-8bd5231f174d 34 fields · synced May 30, 2026