Catalog Number

-

Brand Name

MedSource Continous Flow Nebulizer, Handheld

Version/Model Number

MS-101

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

9f92cf02-f637-4076-a9b9-56f26a8c4ea5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-