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LibAirty Airway Clearance System Vest (S)

FDA UDI

Class II (US FDA UDI)

by Synchrony Medical Ltd

Identity

Trade Name
LibAirty Airway Clearance System Vest (S) FDA UDI
Generic Name
Chest-oscillation airway secretion-clearing system FDA UDI
Model / Reference
L4MV0001 FDA UDI

Identifiers

Primary DI / UDI-DI
07290020062017 FDA UDI
510(k) Number
K242063 FDA UDI
FDA Product Code
BYI FDA UDI
GMDN Term
Chest-oscillation airway secretion-clearing system 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Chest-oscillation airway secretion-clearing system

LibAirty Airway Clearance System Vest (S) by Synchrony Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chest-oscillation airway secretion-clearing system.

Cleared under the same submission

K242063 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synchrony Medical Ltd

Sources (1)

  • FDA UDI 1e95bce5-041f-4d85-8e3e-33884a28d7be 34 fields · synced May 30, 2026