Catalog Number

-

Brand Name

Portex

Version/Model Number

008235

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K952214,K952214

Product Code

NHK

Product Code Name

RESUSCITATOR,MANUAL,NON SELF-INFLATING

Public Device Record Key

b85d2279-e6d2-44a7-9847-1d561692f9a0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

30351688404439

Quantity per Package

20

Contains DI Package

10351688404435

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX