Duns Number:316150549
Device Description: Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis.
Catalog Number
114746M
Brand Name
REVACLEAR
Version/Model Number
Revaclear 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
70a662a0-55d0-4714-ac15-8db5fb43b3b6
Public Version Date
October 11, 2022
Public Version Number
2
DI Record Publish Date
November 08, 2021
Package DI Number
37332414126200
Quantity per Package
24
Contains DI Package
07332414126209
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. | 23 |