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AirPhysio

FDA UDI

Class II (US FDA UDI)

by Airphysio Pty. Ltd.

Identity

Trade Name
AirPhysio FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
mucus clearance average lung capacity, OPEP, non invitro, no chemicals, contains one steel ball bearing TEAL coloured box FDA UDI
Model / Reference
1 FDA UDI
Description
mucus clearance average lung capacity, OPEP, non invitro, no chemicals, contains one steel ball bearing TEAL coloured box FDA UDI

Identifiers

Primary DI / UDI-DI
B99893699980215050 FDA UDI
510(k) Number
K203209 FDA UDI
FDA Product Code
BYI FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5665 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

AirPhysio by Airphysio Pty. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Positive pressure airway secretion-clearing device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Airphysio Pty. Ltd.

Sources (1)

  • FDA UDI 08bb5111-b497-4476-97d9-3fb1f8ee9595 36 fields · synced May 30, 2026