Catalog Number

-

Brand Name

Portex

Version/Model Number

8520B

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

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

K991861,K991861

Product Code

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

fe819ced-1827-4952-8af6-22014a6064da

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2015

Package DI Number

30351688427179

Quantity per Package

9

Contains DI Package

10351688427175

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX