Duns Number:929768682
Device Description: Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis
Catalog Number
114745L
Brand Name
REVACLEAR
Version/Model Number
300
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
ebdae05d-c755-4ed6-bb61-0692b9c6270f
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
February 08, 2017
Package DI Number
37332414123056
Quantity per Package
24
Contains DI Package
07332414123055
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 |