Catalog Number

-

Brand Name

Patient Monitor

Version/Model Number

G3N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K092970,K092970

Product Code

MHX

Product Code Name

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Public Device Record Key

c94f92af-bbc7-43ab-ab2d-9eeb7fd85e0e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 19, 2016

Package DI Number

06938368100176

Quantity per Package

1

Contains DI Package

06938368100169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-