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U.S. Department of Health and Human Services

Product Classification

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Device adminstration set securement device
Regulation Description Intravascular catheter securement device.
Definition Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices.
Physical State Can 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 line/tubing) is the manually secured to the accessory.
Technical Method Mechanical connects / attaches to medical bed, wheelchair or mobile patient medical equipment.
Target Area Hospital beds, wheelchairs, stretchers.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePUK
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(K) Exempt
Regulation Number 880.5210
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible