Administration Set Securement Device

Device Code: 2757

Product Code(s): PUK

Definition: Accessory Device That Secures Intravenous Administration Sets (IV Lines/tubing) To Mobile Transport Devices.

Device Classification Information

Device Type ID2757
Device NameAdministration Set Securement Device
Physical StateCan Be Made Of Molded Plastics, Metal, Hook And Loop Tape For Attachment To Various Patient Transport Medical Devices By Means Of A Securement. Once The Accessory Device Is Secured To Patient Transfer Device, The Intravenous Administration Set (IV Li
Technical MethodMechanical Connects / Attaches To Medical Bed, Wheelchair Or Mobile Patient Medical Equipment.
Target AreaHospital Beds, Wheelchairs, Stretchers.
Regulation DescriptionIntravascular Catheter Securement Device.
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 Number880.5210 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodePUK
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2757
DeviceAdministration Set Securement Device
Product CodePUK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionIntravascular Catheter Securement Device.
CFR Regulation Number880.5210 [🔎]
Device Problems
Migration Or Expulsion Of Device
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:18:23

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