Catalog Number

-

Brand Name

Portex

Version/Model Number

008012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 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

K952169,K952169

Product Code

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

394b7db3-737e-4d86-a9b2-0db3f2d824df

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

October 12, 2015

Package DI Number

30351688402640

Quantity per Package

10

Contains DI Package

10351688402646

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Box