Duns Number:605213545
Device Description: Saline Solution (0.85%) is a saline solution for viral specimens.
Catalog Number
11-612-001
Brand Name
Saline Solution (0.85%)
Version/Model Number
1612
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSG
Product Code Name
Culture Media, Non-Selective And Non-Differential
Public Device Record Key
43e96a2f-6d14-426e-b57b-7197a286d9f9
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
September 29, 2020
Package DI Number
B08816121
Quantity per Package
1
Contains DI Package
B08816120
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box