Peracidin RO Disinfectant - Peracidin® RO Disinfectant is intended for the - ANGELINI PHARMA INC.

Duns Number:078843940

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

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More Product Details

Catalog Number

1633G

Brand Name

Peracidin RO Disinfectant

Version/Model Number

Gallon

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Device Record Status

Public Device Record Key

2e443b57-c849-4f66-9695-ab9bd4099a0a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANGELINI PHARMA INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11