Duns Number:059295980
Device Description: The single-use device is in a color coded unit blow fill sealed container with liquid cont The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. Thedevice contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 100 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
Catalog Number
-
Brand Name
Sodium Chloride Inhalation Solution, USP, 0.9% 3mL UDV
Version/Model Number
3mL
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
-
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
e6bb5323-1990-4715-a821-d28a1f7b5caf
Public Version Date
January 21, 2022
Public Version Number
4
DI Record Publish Date
December 13, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |