Duns Number:203940515
Device Description: The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrog The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Catalog Number
SA-400-00
Brand Name
SAMI RRT Cassette
Version/Model Number
SA-400-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KDI
Product Code Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Public Device Record Key
6bdfc835-a56e-4cca-bb63-f256a3a4de9b
Public Version Date
February 15, 2021
Public Version Number
2
DI Record Publish Date
December 09, 2019
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. | 7 |