Identity
- Trade Name
- PeraSidual FDA UDI
- Generic Name
- Hydrogen peroxide device disinfectant/sterilant test strip FDA UDI
- Device Name
- Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid. FDA UDI
- Model / Reference
- 1702-01 FDA UDI
- Description
- Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid. FDA UDI
Identifiers
- Catalog Number
- 1702-01 FDA UDI
- Primary DI / UDI-DI
- 00898021000235 FDA UDI
- 510(k) Number
- K974798 FDA UDI
- FDA Product Code
- LIF FDA UDI
- GMDN Term
- Hydrogen peroxide device disinfectant/sterilant test strip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 3.25 Inch FDA UDIWidth — 0.2 Inch FDA UDI
Category: Hydrogen peroxide device disinfectant/sterilant test strip
PeraSidual by Angelini Pharma Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hydrogen peroxide device disinfectant/sterilant test strip.
- RenalCheck PX — IBT Scientific · Class II
- Micro-X — Reprocessing Products Corp · Class II
- UltrOx — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- PeraChek — Angelini Pharma Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Angelini Pharma Inc.
Sources (1)
- FDA UDI 6c5c652b-61e0-41c2-992f-1512274f18b4 38 fields · synced Jun 9, 2026