Peracidin RO Disinfectant

Peracidin® RO Disinfectant is intended for the disinfection of water purification systems for hemodialysis.

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MED
Manufacturer City Province Registered as Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 5

Record

Regulatory record for Peracidin RO Disinfectant
Listed by Angelini Pharma Inc., United States
FDA product code MED
Device type Sterilant, Medical Devices
Device class Class 2
Regulation 21 CFR 880.6885
Establishment Contract manufacturer, Manufacturer, Exporter
Premarket notification Exempt
Record published 2017-08-04
Record revised 2023-02-15 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.; Special storage condition: Avoid contamination from any source, including metals, dust, organic matter, etc. Such contamination may cause rapid dec; Special storage condition: Explosive pressure rupture of the container can occur if not properly vented.; Special storage condition: Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
Packaging Case of 4

Catalogue Numbers

Catalogue numbers for Peracidin RO Disinfectant
Catalogue number Size Status
Gallon In distribution
Quarts In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sterilant, Medical Devices Steris Corporation 149
Formed Irrigating Cystotomes Sterimedix Ltd. 37
Hydrodissection Cannulae Sterimedix Ltd. 29
Sterilant, Medical Devices Corporation Steris Canada 29
Anterior Chamber Maintenance Cannulae Sterimedix Ltd. 17
Anaesthetic Needles Sterimedix Ltd. 14
Formed Capsularhexis Cystotomes Sterimedix Ltd. 8
Refractive Cannulae Sterimedix Ltd. 8
enspire Corporation Steris Canada 8
Cidex™ Advanced Sterilization Products Services Inc. 8
Bimanual Cannulae and Hand Pieces Sterimedix Ltd. 7
Bimanual I/A Systems Sterimedix Ltd. 7

Showing 12 of 96. All products under Sterilant, Medical Devices

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer