Catalog Number

-

Brand Name

Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped

Version/Model Number

3 mL

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

8d0e8a92-2e20-4ab4-9de5-085a3db24867

Public Version Date

May 24, 2022

Public Version Number

1

DI Record Publish Date

May 16, 2022

Package DI Number

10376204300022

Quantity per Package

12

Contains DI Package

00376204300025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-