Tube, Tracheal, Reprocessed

Device Code: 162

Product Code(s): NMA

Device Classification Information

Device Type ID162
Device NameTube, Tracheal, Reprocessed
Regulation DescriptionTracheal Tube.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number868.5730 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNMA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID162
DeviceTube, Tracheal, Reprocessed
Product CodeNMA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTracheal Tube.
CFR Regulation Number868.5730 [🔎]
TPLC Last Update: 2019-04-02 19:29:56

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