Duns Number:086785110
Device Description: The BACT/ALERT FN Culture Bottles are used for enhanced recovery and detection of anaerobi The BACT/ALERT FN Culture Bottles are used for enhanced recovery and detection of anaerobic microorganisms from blood, and other normally sterile body fluids.
Catalog Number
-
Brand Name
BACT/ALERT® FN
Version/Model Number
BACT/ALERT® FN
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
K020815,K020815,K020815
Product Code
MDB
Product Code Name
System, blood culturing
Public Device Record Key
33e35a85-53fc-4e79-a3ac-803b691fd5ef
Public Version Date
May 01, 2020
Public Version Number
1
DI Record Publish Date
April 23, 2020
Package DI Number
03573026611828
Quantity per Package
50
Contains DI Package
03573026595920
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 |