Duns Number:039981550
Device Description: Columbia Broth, 8ml fill, 16x125mm glass tube, order by the package of 20For use in the cu Columbia Broth, 8ml fill, 16x125mm glass tube, order by the package of 20For use in the cultivation of fastidious microorganisms
Catalog Number
K74
Brand Name
N/A
Version/Model Number
K74
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZI
Product Code Name
Culture Media, Enriched
Public Device Record Key
4d623cd4-a02e-4e5f-aaa9-fa2387a860f4
Public Version Date
June 10, 2020
Public Version Number
1
DI Record Publish Date
June 02, 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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |