Catalog Number

-

Brand Name

Portex

Version/Model Number

4307SM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 29, 2018

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

K901315,K901315

Product Code

CAF

Product Code Name

NEBULIZER (DIRECT PATIENT INTERFACE)

Public Device Record Key

b56e3100-16d8-4bdc-90ee-6ae577c408a4

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

October 11, 2016

Package DI Number

50351688517263

Quantity per Package

50

Contains DI Package

10351688517265

Package Discontinue Date

October 29, 2018

Package Status

Not in Commercial Distribution

Package Type

CASE