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.
Catalog Number
1633Q
Brand Name
Peracidin RO Disinfectant
Version/Model Number
Quarts
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
7ee58d97-897e-49ee-9d79-039824dc3a2a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 04, 2017
Package DI Number
00898021000310
Quantity per Package
4
Contains DI Package
00898021000297
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |