Duns Number:086785110
Device Description: The BacT/ALERT 3D Control Module enables up to 6 incubator modules to be operated from one The BacT/ALERT 3D Control Module enables up to 6 incubator modules to be operated from one integrated touchscreen computer.
Catalog Number
-
Brand Name
BACT/ALERT® 3D CONTROL MODULE
Version/Model Number
210147
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
K903505,K981736
Product Code
MDB
Product Code Name
System, blood culturing
Public Device Record Key
a78087a5-fd05-4219-97f6-13c2ad073498
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
October 23, 2020
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |