Duns Number:117472366
Device Description: Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment com Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
Catalog Number
2.0.0.0
Brand Name
Regulated Software Application (RSA), Version 2.0
Version/Model Number
2.0.0.0
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
BK200512
Product Code
MMH
Product Code Name
Blood Establishment Computer Software And Accessories
Public Device Record Key
5c8a4729-1861-44b8-bffb-082854928c62
Public Version Date
June 09, 2021
Public Version Number
2
DI Record Publish Date
April 30, 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. | 2 |