Catalog Number

-

Brand Name

Hyperinflation System

Version/Model Number

10-55847

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 06, 2021

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

173a1ad3-5b6c-4d0c-8db9-5bb396fb51a5

Public Version Date

May 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2015

Package DI Number

30641043558472

Quantity per Package

20

Contains DI Package

10641043558478

Package Discontinue Date

May 06, 2021

Package Status

Not in Commercial Distribution

Package Type

-