Trap, Sterile Specimen

Device Code: 2533

Product Code(s): BYZ

Device Classification Information

Device Type ID2533
Device NameTrap, Sterile Specimen
Regulation DescriptionVacuum-powered Body Fluid Suction Apparatus.
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 Number880.6740 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBYZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2533
DeviceTrap, Sterile Specimen
Product CodeBYZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionVacuum-powered Body Fluid Suction Apparatus.
CFR Regulation Number880.6740 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Medline Industries Inc
II May-13-2014
TPLC Last Update: 2019-04-02 20:13:52

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