Bottle, Hot/cold Water

Device Code: 2581

Product Code(s): FPF

Device Classification Information

Device Type ID2581
Device NameBottle, Hot/cold Water
Regulation DescriptionHot/cold Water Bottle.
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 Number880.6085 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFPF
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2581
DeviceBottle, Hot/cold Water
Product CodeFPF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionHot/cold Water Bottle.
CFR Regulation Number880.6085 [🔎]
Device Problems
Leak / Splash
1
Fluid Leak
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:15:16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.