Catalog Number

na

Brand Name

Proneb Max

Version/Model Number

130F83-LC+

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

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

3bfc86e0-6331-462f-a1f7-db2f3cd3de32

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 22, 2020

Package DI Number

00744229100713

Quantity per Package

6

Contains DI Package

00744229130024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton