Catalog Number

-

Brand Name

Proneb Ultra

Version/Model Number

085P0012P12

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

K002862,K002862

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

9f6e9217-7e7b-45de-85c9-0e44f33cd0b5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 17, 2016

Package DI Number

00744229850359

Quantity per Package

12

Contains DI Package

00744229850090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton