Duns Number:117472366
Device Description: The Regulated Software Application (RSA) is a system of co-dependent web based computer pr The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.
Catalog Number
1.0.33.0
Brand Name
Regulated Software Application (RSA)
Version/Model Number
1.0.33.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 18, 2021
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
BK110048
Product Code
MMH
Product Code Name
Blood Establishment Computer Software And Accessories
Public Device Record Key
65e232db-0c6c-4f25-be06-bd612f8a8f02
Public Version Date
June 09, 2021
Public Version Number
2
DI Record Publish Date
April 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |