Duns Number:623214079
Device Description: ViraTrans™, Viral Transport Media
Catalog Number
B1029-35D
Brand Name
Bartels
Version/Model Number
B1029-35D
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
-
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
JSM
Product Code Name
Culture Media, Non-Propagating Transport
Public Device Record Key
c6b5cb9d-0850-457f-8ecd-2a9a761a4ab1
Public Version Date
November 04, 2019
Public Version Number
1
DI Record Publish Date
October 25, 2019
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 | 50 |
2 | A medical device with a moderate to high risk that requires special controls. | 116 |