Duns Number:825673239
Device Description: AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 5mL
Catalog Number
ASR0059
Brand Name
AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 5mL
Version/Model Number
1
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"
Yes
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
-
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
6be2fe12-886f-40a8-9f81-ad8865a3ad96
Public Version Date
May 20, 2019
Public Version Number
1
DI Record Publish Date
May 12, 2019
Package DI Number
40704411010303
Quantity per Package
10
Contains DI Package
30704411010306
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 89 |
2 | A medical device with a moderate to high risk that requires special controls. | 411 |
U | Unclassified | 1 |