PUKClass I
Administration Set Securement Device
21 CFR 880.5210 / General Hospital
PUK is the FDA product code for Administration Set Securement Device, a class I device type, regulated under 21 CFR 880.5210. FDA's definition for this code reads: "Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- PUK
- Device name
- Administration Set Securement Device
- FDA definition
- Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices.
- Regulation
- 21 CFR 880.5210
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
