Catalog Number

Not Applicable

Brand Name

MedSource Nebulizer

Version/Model Number

MS-101-RCS

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

ebc016c0-0638-4543-bf37-5a53131dc81c

Public Version Date

May 05, 2021

Public Version Number

1

DI Record Publish Date

April 27, 2021

Package DI Number

00816703024461

Quantity per Package

50

Contains DI Package

00816703024454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case