Duns Number:086785110
Device Description: Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative pro Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of a variety of anaerobic and facultative microorganisms
Catalog Number
-
Brand Name
BACT/ALERT®
Version/Model Number
BACT/ALERT®
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
-
Product Code
GIM
Product Code Name
Tubes, vacuum sample, with anticoagulant
Public Device Record Key
f5a458b2-e818-4673-9a4d-09d3549c381f
Public Version Date
October 25, 2021
Public Version Number
2
DI Record Publish Date
April 17, 2020
Package DI Number
03573026209360
Quantity per Package
1
Contains DI Package
03573026616694
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 |