Catalog Number

-

Brand Name

Portex

Version/Model Number

R0059

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 20, 2019

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"

Yes

For Single-Use

Yes

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

-

Product Code

CAF

Product Code Name

NEBULIZER (DIRECT PATIENT INTERFACE)

Public Device Record Key

8f38ce75-0081-4ee3-ac1d-cbb2a5d38317

Public Version Date

November 22, 2019

Public Version Number

4

DI Record Publish Date

December 01, 2016

Package DI Number

50351688600019

Quantity per Package

10

Contains DI Package

00351688600014

Package Discontinue Date

November 20, 2019

Package Status

Not in Commercial Distribution

Package Type

Case