Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.

• Trade Name: IBV VALVE SYSTEM
• Classification Name: one-way air-leak valve
• Generic Name: one-way air-leak valve
• Applicant: Gyrus ACMI, Inc.; 6675 185th avenue ne; redmond, WA 98052
• HDE Number: H060002
• Supplement Number: S003
• Date Received: 04/06/2009
• Decision Date: 05/07/2009
• Product Code: OAZ [ Registered Establishments with OAZ ]
• Advisory Committee: Anesthesiology
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No