Portable Liquid Oxygen Unit Stand

Device Code: 221

Product Code(s): PCM

Definition: To Assist The User With Refilling A Portable Liquid Oxygen Tank From A Reservoir Unit By Holding The Portable Liquid Oxygen Tank In An Upright Position.

Device Classification Information

Device Type ID221
Device NamePortable Liquid Oxygen Unit Stand
Physical StatePortable Liquid Oxygen Unit
Technical MethodPhysically Maintains The Portable Liquid Oxygen Tank In An Upright Position
Target AreaPortable Liquid Oxygen Tanks And Reservoir Units
Regulation DescriptionDaily Activity Assist Device.
Regulation Medical SpecialtyPhysical Medicine
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 Number890.5050 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodePCM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID221
DevicePortable Liquid Oxygen Unit Stand
Product CodePCM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDaily Activity Assist Device.
CFR Regulation Number890.5050 [🔎]
TPLC Last Update: 2019-04-02 19:30:52

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