Duns Number:964900463
Device Description: Bloodstream Software is a standalone software application used in blood screening. Bloodst Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
Catalog Number
BSB01
Brand Name
Bloodstream Software
Version/Model Number
1.0
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PQQ
Product Code Name
Data Acquisition Software
Public Device Record Key
0ad388d4-d5c9-4919-8670-8e14fdff98a5
Public Version Date
June 08, 2022
Public Version Number
1
DI Record Publish Date
May 31, 2022
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. | 5 |