Catalog Number

-

Brand Name

Portex

Version/Model Number

008432T

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

K970785,K970785

Product Code

NHK

Product Code Name

RESUSCITATOR,MANUAL,NON SELF-INFLATING

Public Device Record Key

95cc8160-15ae-48d1-8105-0679baed3d60

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

30351688423317

Quantity per Package

15

Contains DI Package

10351688423313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX