NITRONOX INHALATION HOSPITAL MIXER ANALGESIA MACHINE - NITRONOX,HOSPITAL W/DEM VALVE - PARKER-HANNIFIN CORPORATION

Duns Number:004175550

Device Description: NITRONOX,HOSPITAL W/DEM VALVE

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


More Product Details

Catalog Number

-

Brand Name

NITRONOX INHALATION HOSPITAL MIXER ANALGESIA MACHINE

Version/Model Number

NOX-5000HD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K760766

Product Code Details

Product Code

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Device Record Status

Public Device Record Key

0ea34771-d6e6-4e1b-9068-6be7094b0007

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKER-HANNIFIN CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 49