Duns Number:073169765
Device Description: BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility processing for blood donors. It is used for manufacturing blood products and for shipping those products to customer hospitals for eventual transfusion.
Catalog Number
-
Brand Name
Blood Bank Information Management System
Version/Model Number
2.06
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
BK180246
Product Code
MMH
Product Code Name
Blood Establishment Computer Software And Accessories
Public Device Record Key
e2bdf424-a66a-4064-9a4b-dd4f1c78e3e2
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 30, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |