Duns Number:039981550
Device Description: NaCl 6.5% Broth with indicator, salt tolerance broth, 2mL, 15x103mm tube, optically clear, NaCl 6.5% Broth with indicator, salt tolerance broth, 2mL, 15x103mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20, (Salt Tolerance Broth with BCP indicator) For the identification of Enterococcus spp.
Catalog Number
K49
Brand Name
N/A
Version/Model Number
K49
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
JSJ
Product Code Name
Culture Media, Selective And Non-Differential
Public Device Record Key
3de0ae63-6498-4672-81b4-fbe6d7a5f910
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 |