Bag, Ice

Device Code: 2635

Product Code(s): KYR

Device Classification Information

Device Type ID2635
Device NameBag, Ice
Regulation DescriptionIce Bag.
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 Number880.6050 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKYR
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2635
DeviceBag, Ice
Product CodeKYR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionIce Bag.
CFR Regulation Number880.6050 [🔎]
TPLC Last Update: 2019-04-02 20:16:30

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