Duns Number:008496861
Device Description: A modified Carey and Blair Medium intended to be used for the preservation and transport o A modified Carey and Blair Medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen.
Catalog Number
2805-05
Brand Name
C&S Medium
Version/Model Number
2805-05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K150887,K150887
Product Code
JSM
Product Code Name
Culture Media, Non-Propagating Transport
Public Device Record Key
5b24258d-aec0-412e-b860-51e883e7d9f0
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |