Duns Number:011702541
Device Description: Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL via Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic
Catalog Number
50190-740-60
Brand Name
PulmoSal 7% (pH+)
Version/Model Number
74060
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
K130091,K130091,K130091
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
8dfc3710-fa57-44c4-9115-20b7da3cec28
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
60850877007037
Quantity per Package
12
Contains DI Package
40850877007033
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case