VIBRALUNG®

GUDID 10709078002417

VIBRALUNG® HHT Hanger

WESTMED, INC.

Electroacoustical airway secretion-clearing system

• Primary Device ID: 10709078002417
• NIH Device Record Key: 9b3f9d38-3792-4a98-8c7e-db5d7560d63d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIBRALUNG®
• Version Model Number: 9641
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078002410 [Primary]
GS1	10709078002417 [Package]; Contains: 00709078002410; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133057

FDA Product Code

• BYI: Percussor, Powered-Electric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-19

On-Brand Devices [VIBRALUNG®]

• 10709078002417: VIBRALUNG® HHT Hanger
• 00709078002403: Demo User Kit with Travel Bag, VIBRALUNG®
• 00709078002397: Demo Treatment Control Unit Assembly, VIBRALUNG® Acoustical