Duns Number:039981550
Device Description: Purple Broth with Trehalose, 10ml fill, 16x125mm tube with durham tube, order by the packa Purple Broth with Trehalose, 10ml fill, 16x125mm tube with durham tube, order by the package of 20For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
Catalog Number
Y116
Brand Name
N/A
Version/Model Number
Y116
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
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
efaf261f-b703-4848-88c0-c5d2742e0eed
Public Version Date
June 17, 2020
Public Version Number
1
DI Record Publish Date
June 09, 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 |