Duns Number:929768682
Device Description: Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by he Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis
Catalog Number
114746L
Brand Name
REVACLEAR
Version/Model Number
400
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
K130039,K130039
Product Code
KDI
Product Code Name
Dialyzer, high permeability with or without sealed dialysate system
Public Device Record Key
3a794490-7924-4d88-ab58-07758b60200d
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
January 15, 2018
Package DI Number
37332414124077
Quantity per Package
24
Contains DI Package
07332414124076
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. | 4 |