Pps Pi U201912
Pps Pi U201912 is a Class II device made by Perouse Medical, cleared under FDA 510(k) K120261 on 2 May 2012 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 03661234011209), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03661234011209 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120261 | Date2 May 2012 | StatusActive |
Official records
- AccessGUDID record 03661234011209
- FDA 510(k) database K120261
Across registries
- FDA 510(k) K120261 decided 2 May 2012 Active
- FDA GUDID UDI-DI 03661234011209 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K120261
- Listed FDA GUDID 03661234011209
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pps Pi
- Generic name
- Subcutaneous infusion/injection port needle
- Model / reference
- U201912
- Primary DI / UDI-DI
- 03661234011209
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Subcutaneous infusion/injection port needle
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code FMI (Needle, hypodermic, single lumen).
- EZ-MIO STERNAL by Vidacare Corporation
- Safe Cap Needle Recapping/Uncapping Device by Medi-Dose, Inc.
- KG MEDIX DISPOSABLE SYRING, 1, 3, 5, 10, 20, 30, 50 ML'S, KG MEDIX by Kyung GI Medical Ind. Co., Ltd.
- ARROW IPN915665 9040 by TELEFLEX INCORPORATED
- Amipaque Myelogram Tray by Pharmaseal Div., Baxter Healthcare Corp.
- Darwin Hypodermic Safety System (DHSS) by Emk Enterprises, LLC
- BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY by BECTON, DICKINSON & CO.
- VACUETTE MULTIPLE SAMPLE LUER ADAPTER by Greiner Meditech, Inc.
- FILTER DEVICES by Arrow Intl., Inc.
- EXEL HUBER NEEDLE by Exel Intl.