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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 (package of 10) FDA UDI
Model / Reference
110501 FDA UDI
Description
AEROBIKA Oscillating Positive Expiratory Pressure Therapy System (package of 10) FDA UDI

Identifiers

Catalog Number
11050194010 FDA UDI
Primary DI / UDI-DI
62860110501022 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
Not 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

AEROBIKA Oscillating Positive Expiratory Pressure Therapy System by Trudell Medical International — Class II — FDA UDI — listed in FDA GUDID

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 1e8f2f60-269a-4885-b73e-adbb803cdf88 37 fields · synced Jun 1, 2026