Catalog Number

-

Brand Name

Portex

Version/Model Number

8515C

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

K023793,K023793

Product Code

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

11e34fef-7667-4089-830d-f317be9e6f23

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2015

Package DI Number

30351688431336

Quantity per Package

9

Contains DI Package

10351688431332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX