Washer Of Body Waste Receptacles

Device Code: 2542

Product Code(s): FLH

Device Classification Information

Device Type ID2542
Device NameWasher Of Body Waste Receptacles
Regulation DescriptionWashers For Body Waste Receptacles.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.6800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFLH
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2542
DeviceWasher Of Body Waste Receptacles
Product CodeFLH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionWashers For Body Waste Receptacles.
CFR Regulation Number880.6800 [🔎]
Device Problems
Device Emits Odor
3
Off-Label Use
1
Installation-Related Problem
1
Incorrect, Inadequate Or Imprecise Result Or Readings
1
Fire
1
Difficult To Open Or Close
1
Total Device Problems 8
TPLC Last Update: 2019-04-02 20:14:03

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