Duns Number:039981550
Device Description: BlueMount™, permanent fungal stain, lactophenol cotton blue with PVA, 15ml eachA permanent BlueMount™, permanent fungal stain, lactophenol cotton blue with PVA, 15ml eachA permanent slide mounting media for mycology specimens that contains the stain lactophenol cotton blue. Produces a long lasting permanently stained slide. Contains polyvinyl alcohol (PVA) that will dry and set up hard to create a perfectly preserved slide.
Catalog Number
Z137
Brand Name
BlueMount™
Version/Model Number
Z137
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
JTO
Product Code Name
Discs, Strips And Reagents, Microorganism Differentiation
Public Device Record Key
102441c9-c3c1-4313-a6f6-937fb731c1bd
Public Version Date
June 19, 2020
Public Version Number
1
DI Record Publish Date
June 11, 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 |