Catalog Number

-

Brand Name

Portex

Version/Model Number

H1051

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

K952214,K952214

Product Code

NHK

Product Code Name

RESUSCITATOR,MANUAL,NON SELF-INFLATING

Public Device Record Key

18f55266-b728-4ecb-9344-d4d8133f7e29

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2015

Package DI Number

30351688434672

Quantity per Package

20

Contains DI Package

10351688434678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX