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AEROBIKA Oscillating Positive Expiratory Pressure Therapy System

FDA UDI

Class II (US FDA UDI)

by Trudell Medical International

Identity

Trade Name
AEROBIKA Oscillating Positive Expiratory Pressure Therapy System FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
AEROBIKA Oscillating Positive Expiratory Pressure Therapy System FDA UDI
Model / Reference
110501 FDA UDI
Description
AEROBIKA Oscillating Positive Expiratory Pressure Therapy System FDA UDI

Identifiers

Primary DI / UDI-DI
00762860105010 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 Oscillating Positive Expiratory Pressure Therapy System by Trudell Medical International — Class II — FDA UDI — listed in FDA GUDID

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
Trudell Medical International

Sources (1)

  • FDA UDI 79a4d622-b208-4612-acb0-c7d38564946a 35 fields · synced Jun 6, 2026