Duns Number:052934841
Device Description: Sunquest Transfusion Manager is blood bank information system application software
Catalog Number
-
Brand Name
Sunquest Transfusion Manager
Version/Model Number
2.x
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
MMH
Product Code Name
Blood Establishment Computer Software And Accessories
Public Device Record Key
7c2c1112-fb8a-4e31-94ea-0de07f2a1567
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
June 06, 2018
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |