Duns Number:086785110
Device Description: BacT/ALERT BPA (aerobic culture) bottles are used for QC testing of leukocyte reduced aphe BacT/ALERT BPA (aerobic culture) bottles are used for QC testing of leukocyte reduced apheresis platelet units,leukocyte reduced single units of whole blood platelet concentrates
Catalog Number
-
Brand Name
BACT/ALERT® BPA
Version/Model Number
BACT/ALERT® BPA
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
Yes
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
BK050037,BK050037,BK050037
Product Code
MZC
Product Code Name
System, detection, bacterial, for platelet transfusion products
Public Device Record Key
ea376703-30e3-4082-b568-cc156f407c58
Public Version Date
May 05, 2020
Public Version Number
1
DI Record Publish Date
April 27, 2020
Package DI Number
03573026126742
Quantity per Package
2
Contains DI Package
03573026611859
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |