← Back to catalogue

PeraChek

FDA UDI

Class II (US FDA UDI)

by Angelini Pharma Inc.

Identity

Trade Name
PeraChek FDA UDI
Generic Name
Hydrogen peroxide device disinfectant/sterilant test strip FDA UDI
Device Name
Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing. FDA UDI
Model / Reference
1701-01 FDA UDI
Description
Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing. FDA UDI

Identifiers

Catalog Number
1701-01 FDA UDI
Primary DI / UDI-DI
00898021000242 FDA UDI
510(k) Number
K980164 FDA UDI
FDA Product Code
MSY FDA UDI
LIF FDA UDI
GMDN Term
Hydrogen peroxide device disinfectant/sterilant test strip FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5665 FDA UDI
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
Width — 0.2 Inch FDA UDI
Length — 3.25 Inch FDA UDI

Category: Hydrogen peroxide device disinfectant/sterilant test strip

PeraChek 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Angelini Pharma Inc.

Sources (1)

  • FDA UDI e5e52977-ef04-4b6d-a861-2d86b449ef23 38 fields · synced Jun 9, 2026