Cabinet, Table And Tray, Anesthesia

Device Code: 3

Product Code(s): BRY

Device Classification Information

Device Type ID3
Device NameCabinet, Table And Tray, Anesthesia
Regulation DescriptionAnesthetic Cabinet, Table, Or Tray.
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) Exempt
CFR Regulation Number868.6100 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBRY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3
DeviceCabinet, Table And Tray, Anesthesia
Product CodeBRY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAnesthetic Cabinet, Table, Or Tray.
CFR Regulation Number868.6100 [🔎]
Device Problems
No Apparent Adverse Event
9
Mechanical Problem
2
Overheating Of Device
1
Material Separation
1
Patient Device Interaction Problem
1
Material Frayed
1
Device Inoperable
1
Power Problem
1
Device Operational Issue
1
Total Device Problems 18
Recalls
Manufacturer Recall Class Date Posted
1
B. Braun Medical, Inc.
II May-04-2015
2
CareFusion 303, Inc.
II Feb-16-2016
3
Stryker Communications
II Jul-15-2014
TPLC Last Update: 2019-04-02 19:07:21

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