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U.S. Department of Health and Human Services

Product Classification

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Device tube tracheostomy and tube cuff
Regulation Description Tracheostomy tube and tube cuff.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeJOH
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review
Accredited Persons
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