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Aerobika, OPEP

FDA UDI

Class II (US FDA UDI)

by Monaghan Medical Corp.

Identity

Trade Name
Aerobika,OPEP FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
AEROBIKA, OPEP DEVICE, RETAIL- 50512 FDA UDI
Model / Reference
Aerobika, OPEP Device, Retail FDA UDI
Description
AEROBIKA, OPEP DEVICE, RETAIL- 50512 FDA UDI

Identifiers

Primary DI / UDI-DI
00604351505124 FDA UDI
510(k) Number
K123400 FDA UDI
FDA Product Code
BWF FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Positive pressure airway secretion-clearing device

Aerobika, OPEP by Monaghan Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Positive pressure airway secretion-clearing device.

Cleared under the same submission

K123400 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monaghan Medical Corp.

Sources (1)

  • FDA UDI ad30c5a3-4198-4620-915a-9ea672d5f1a4 35 fields · synced May 30, 2026