Administration Set Securement Device
The Administration Set Securement Device is a general hospital accessory device designed to secure intravenous administration sets and IV lines or tubing to mobile transport devices, preventing accidental dislodgement during patient transport or movement. It is classified as FDA Class I under regulation 21 CFR 880.5210, meaning it is subject only to general controls and is exempt from premarket notification (510(k)) requirements. The product code is PUK and it falls under the General Hospital medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PUK
- Device Class
- FDA class 1
- Regulation Number
- 880.5210
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices.
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.