Duns Number:177240249
Device Description: Blood Centers is a comprehensive, modular, computerized system intended to be used by trai
Catalog Number
-
Brand Name
WellSky Blood Centers
Version/Model Number
2022
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"
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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
BK180200
Product Code
MMH
Product Code Name
Blood Establishment Computer Software And Accessories
Public Device Record Key
be6a377e-ed8e-44b8-91b9-b79e8970f97c
Public Version Date
February 18, 2022
Public Version Number
1
DI Record Publish Date
February 10, 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. | 8 |