Duns Number:354021099
Device Description: Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indica Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body weight of 25 kg or more. To be used by trained operators in chronic care dialysis or hospital care environment. Not intended for Self-care or Home use.
Catalog Number
955607
Brand Name
AK 98
Version/Model Number
955607
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
-
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
K201809
Product Code
KDI
Product Code Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Public Device Record Key
fc37e6f8-721e-4b36-93f1-37ab7a4dde31
Public Version Date
October 19, 2022
Public Version Number
4
DI Record Publish Date
March 22, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |