Catalog Number

-

Brand Name

NuFLO2 Hyperinflation System

Version/Model Number

10-56816

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

bf8609ae-35ff-4f79-8551-6948beb75de6

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

30641043568167

Quantity per Package

20

Contains DI Package

10641043568163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-