Duns Number:929768682
Device Description: Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
Catalog Number
110633
Brand Name
POLYFLUX REVACLEAR
Version/Model Number
110633
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 28, 2020
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
KDI
Product Code Name
Dialyzer, high permeability with or without sealed dialysate system
Public Device Record Key
b6d6c4cb-ccf0-4e52-b672-7bca10a7472e
Public Version Date
December 03, 2020
Public Version Number
6
DI Record Publish Date
October 07, 2015
Package DI Number
37332414101696
Quantity per Package
24
Contains DI Package
07332414101695
Package Discontinue Date
March 28, 2020
Package Status
Not 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. | 4 |