Catalog Number

-

Brand Name

Proneb Max

Version/Model Number

130F1002P12

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,K191270

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

0ee6b124-a6d3-462e-b6c3-bc799bbc226b

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

Package DI Number

00744229100751

Quantity per Package

12

Contains DI Package

00744229130055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton