Duns Number:343689704
Device Description: Diacap Polysulfone® HI PS 15 Dialyzer
Catalog Number
7204102
Brand Name
Diacap®
Version/Model Number
7204102
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 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
FJI
Product Code Name
DIALYZER, CAPILLARY, HOLLOW FIBER
Public Device Record Key
f09121fe-b5a6-49a8-8955-4759a2806257
Public Version Date
August 20, 2021
Public Version Number
5
DI Record Publish Date
August 09, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 69 |
| 3 | A medical device with high risk that requires premarket approval | 1 |