Duns Number:003255213
Device Description: Red Cell Storage Solution is intended for use in the dilution and/or preservation of human Red Cell Storage Solution is intended for use in the dilution and/or preservation of human red blood cells (RBCs) for the purposes of in vitro immunohematology testing.
Catalog Number
-
Brand Name
Red Cell Storage Solution
Version/Model Number
510265
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
-
Product Code
GIF
Product Code Name
Diluent, Blood Cell
Public Device Record Key
dea2fc78-e788-4d92-a9a9-913edb748aea
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
July 17, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |