Product Classification

• Device: multi-patient circuit connector
• Definition: Accessory to single patient ventilator to allow multi-patient ventilation during declared public health emergency
• Physical State: n/a
• Technical Method: n/a
• Target Area: n/a
• Review Panel: Ear Nose & Throat
• Product Code: QOX
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Not Classified Reason: EUA - Emergency Use Authorization
• Submission Type: EUA - Emergency Use Authorization
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible