Catalog Number

-

Brand Name

Portex

Version/Model Number

8501

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"

Yes

For Single-Use

-

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

K014115,K014115,K014115

Product Code

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

a595189f-fe04-40a9-ac15-2f8cdcba0caa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2015

Package DI Number

50351688431538

Quantity per Package

12

Contains DI Package

30351688431534

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE