Duns Number:011702541
Device Description: Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, steri Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
Catalog Number
50190-523-23
Brand Name
NebuSal 6% USP
Version/Model Number
52323
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101424,K101424,K101424
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
ad9712ac-bf5d-4991-8b50-1b47712aee18
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
60850877007013
Quantity per Package
12
Contains DI Package
40850877007019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case