LibAirty Airway Clearance System Vest (L)

GUDID 07290020062031

SYNCHRONY MEDICAL LTD

Chest-oscillation airway secretion-clearing system

• Primary Device ID: 07290020062031
• NIH Device Record Key: e5b7ada6-0cb8-4384-a28a-2a3c05deefdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LibAirty Airway Clearance System Vest (L)
• Version Model Number: L4MV0003
• Company DUNS: 600768341
• Company Name: SYNCHRONY MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290020062031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242063

FDA Product Code

• BYI: Percussor, Powered-Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-27
• Device Publish Date: 2025-05-19

Devices Manufactured by SYNCHRONY MEDICAL LTD

• 07290020062000 - LibAirty Airway Clearance System: 2025-05-27
• 07290020062017 - LibAirty Airway Clearance System Vest (S): 2025-05-27
• 07290020062024 - LibAirty Airway Clearance System Vest (M): 2025-05-27
• 07290020062031 - LibAirty Airway Clearance System Vest (L): 2025-05-27
• 07290020062031 - LibAirty Airway Clearance System Vest (L): 2025-05-27