Catalog Number

-

Brand Name

Proneb Max

Version/Model Number

130F1002

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191270

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

72c3e581-67d8-412c-b362-de26bfdf75d1

Public Version Date

August 03, 2020

Public Version Number

1

DI Record Publish Date

July 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-