Catalog Number

-

Brand Name

Patient Monitor

Version/Model Number

G3R

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

89c64368-1f64-4202-9a73-cf2733fd79cd

Public Version Date

March 15, 2019

Public Version Number

1

DI Record Publish Date

March 07, 2019

Package DI Number

06938368100268

Quantity per Package

1

Contains DI Package

06938368100244

Package Discontinue Date

March 07, 2019

Package Status

Not in Commercial Distribution

Package Type

-