Catalog Number

50190-142-63

Brand Name

NebuSal 3% USP

Version/Model Number

14263

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

8a129b19-b421-44e3-ac68-6c908d1e5547

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

60850877007006

Quantity per Package

12

Contains DI Package

40850877007002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case