PeraSidual 1702-01
PeraSidual 1702-01 is a Class II device made by Angelini Pharma Inc., cleared under FDA 510(k) K974798 on 20 Mar 1998 and listed in FDA GUDID since 23 May 2017 (UDI-DI 00898021000235), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00898021000235 | Date23 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK974798 | Date20 Mar 1998 | StatusActive |
Official records
- AccessGUDID record 00898021000235
- FDA 510(k) database K974798
Across registries
- FDA 510(k) K974798 decided 20 Mar 1998 Active
- FDA GUDID UDI-DI 00898021000235 listed 23 May 2017 Listed
Recalls
-
- Terminated Z-2016-2009
Some of the reagent strip bottles contain the incorrect strips
Timeline
- Cleared FDA 510(k) K974798
- Recall initiated FDA recalls Z-2016-2009
- Listed FDA GUDID 00898021000235
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PeraSidual
- Generic name
- Hydrogen peroxide device disinfectant/sterilant test strip
- Model / Ref / Catalog
- 1702-01
- Primary DI / UDI-DI
- 00898021000235
- 510(k) Number
- FDA product code
- LIF
- GMDN term
- Hydrogen peroxide device disinfectant/sterilant test strip
- Device class
- Class II
- Regulation number
- 876.5820
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 3.25 InchWidth — 0.2 Inch
Similar devices
Other devices filed under FDA product code LIF (Dialyzer Reprocessing System).
- LIXIVITRON by United Medical
- COBE REN NEW-D DISPENSING KIT by Cobe Laboratories, Inc.
- RENATRON by Renal Systems, Inc.
- DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES by Seratronics, Inc.
- MODEL RS 8300 by Renal Systems, Inc.
- SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) by SERIM RESEARCH CORP.
- DIALYZER REPROCESSING SYSTEM DRS-4 by Seratronics, Inc.
- ECHO MM1000 by Mesa Medical, Inc.
- POTENCY TEST STRIPS, INDICATOR TEST STRIPS by Reprocessing Products Corp
- RENALIN REUSE CART by Renal Scientific Service, Inc.