NuFLO2 Hyperinflation System - MERCURY ENTERPRISES, INC.

Duns Number:032705659

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

NuFLO2 Hyperinflation System

Version/Model Number

10-56812

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NHK

Product Code Name

Resuscitator,Manual,Non Self-Inflating

Device Record Status

Public Device Record Key

4c5bb9d7-ff25-45f2-8665-d666955462b2

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

30641043568129

Quantity per Package

20

Contains DI Package

10641043568125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MERCURY ENTERPRISES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 120
2 A medical device with a moderate to high risk that requires special controls. 728