← Back to catalogue

Peracidin®

FDA UDI

Class II (US FDA UDI)

by Angelini Pharma Inc.

Identity

Trade Name
Peracidin® FDA UDI
Generic Name
Organic peroxy acid device sterilant, single-use FDA UDI
Device Name
Dialyzer Reprocessing Concentrate and RO Disinfectant FDA UDI
Model / Reference
Quarts FDA UDI
Description
Dialyzer Reprocessing Concentrate and RO Disinfectant FDA UDI

Identifiers

Catalog Number
081898 FDA UDI
Primary DI / UDI-DI
00898021000402 FDA UDI
510(k) Number
K962959 FDA UDI
FDA Product Code
MED FDA UDI
GMDN Term
Organic peroxy acid device sterilant, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6885 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

Yes

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

Category: Organic peroxy acid device sterilant, single-use

Peracidin® by Angelini Pharma Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Organic peroxy acid device sterilant, single-use.

Cleared under the same submission

K962959 also covers:

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 fe6c4fcd-85bc-452b-9e0a-1836d884af94 37 fields · synced Jun 9, 2026