Mask, Ventilator, Non-continuous, Reprocessed

Device Code: 163

Product Code(s): NMC

Definition: Reprocessed Mask For Use With A Non-continuous Ventilator (CPAP, BiLevel Pressure).

Device Classification Information

• Device Type ID: 163
• Device Name: Mask, Ventilator, Non-continuous, Reprocessed
• Regulation Description: Noncontinuous Ventilator (IPPB).
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Anesthesiology Devices Branch (ANDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.5905 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NMC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 163
• Device: Mask, Ventilator, Non-continuous, Reprocessed
• Product Code: NMC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Noncontinuous Ventilator (IPPB).
• CFR Regulation Number: 868.5905 [🔎]

TPLC Last Update: 2019-04-02 19:29:57