Catalog Number

-

Brand Name

Proneb Ultra

Version/Model Number

085F0012P2

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

508b9735-4bdc-4050-837d-4988928a147d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 17, 2016

Package DI Number

00744229850342

Quantity per Package

12

Contains DI Package

00744229850328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton