Catalog Number

-

Brand Name

Hyperinflation System

Version/Model Number

10-55867

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

K001714,K001714

Product Code

NHK

Product Code Name

Resuscitator,Manual,Non Self-Inflating

Public Device Record Key

34e08df7-6999-4a5d-adb2-efc914a6cbf4

Public Version Date

May 19, 2020

Public Version Number

2

DI Record Publish Date

September 19, 2018

Package DI Number

30641043558670

Quantity per Package

20

Contains DI Package

10641043558676

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-