Catalog Number

-

Brand Name

NuFLO2 Hyperinflation System

Version/Model Number

10-56836

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

1d65adc1-2257-4a42-a9c9-27573668c78f

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

March 15, 2016

Package DI Number

30641043568365

Quantity per Package

20

Contains DI Package

10641043568361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-