Support, Breathing Tube

Device Code: 129

Product Code(s): JAY

Device Classification Information

Device Type ID129
Device NameSupport, Breathing Tube
Regulation DescriptionBreathing Tube Support.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type510(K) Exempt
CFR Regulation Number868.5280 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJAY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID129
DeviceSupport, Breathing Tube
Product CodeJAY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionBreathing Tube Support.
CFR Regulation Number868.5280 [🔎]
Device Problems
Difficult To Insert
2
Component(s), Broken
1
Suction Problem
1
Total Device Problems 4
TPLC Last Update: 2019-04-02 19:29:27

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