Container, Liquid Medication, Graduated

Device Code: 2638

Product Code(s): KYW

Device Classification Information

Device Type ID2638
Device NameContainer, Liquid Medication, Graduated
Regulation DescriptionLiquid Medication Dispenser.
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 Number880.6430 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKYW
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2638
DeviceContainer, Liquid Medication, Graduated
Product CodeKYW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLiquid Medication Dispenser.
CFR Regulation Number880.6430 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Medline Industries Inc
II Aug-11-2016
TPLC Last Update: 2019-04-02 20:16:33

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