Catalog Number

-

Brand Name

Portex

Version/Model Number

8528BM

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

-

Product Code

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

968607cd-3620-4800-89e4-c9739e7c4ba7

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 20, 2018

Package DI Number

35019517101120

Quantity per Package

9

Contains DI Package

15019517101126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case