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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
Gallon FDA UDI
Description
Dialyzer Reprocessing Concentrate and RO Disinfectant FDA UDI

Identifiers

Catalog Number
081894 FDA UDI
Primary DI / UDI-DI
00898021000389 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

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Manufacturer

Manufacturer
Angelini Pharma Inc.

Sources (1)

  • FDA UDI 46d4d1b8-a627-467b-b0d5-257e7775aefa 37 fields · synced Jun 9, 2026