Shikani Speaking Valve

GUDID 00866035000312

Airway Company, The

Tracheostomy tube speech valve

• Primary Device ID: 00866035000312
• NIH Device Record Key: 2b48726c-944b-4d1b-91c2-5ff07d265a6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shikani Speaking Valve
• Version Model Number: SSV-B
• Company DUNS: 063502758
• Company Name: Airway Company, The
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866035000312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100995

FDA Product Code

• JOH: Tube Tracheostomy And Tube Cuff

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: 2019-06-03
• Device Publish Date: 2019-05-24

On-Brand Devices [Shikani Speaking Valve]

• 00866035000312: SSV-B
• 00866035000305: SSV-C