Catalog Number

81842478

Brand Name

Viterion 100 TeleHealth Monitor

Version/Model Number

3.5.0.en

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 12, 2016

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MWI

Product Code Name

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Public Device Record Key

567c55ea-15c6-4a5a-ae49-afefe718c128

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 17, 2016

Package DI Number

10852579007006

Quantity per Package

5

Contains DI Package

00852579007009

Package Discontinue Date

December 12, 2016

Package Status

Not in Commercial Distribution

Package Type

Inner Pack (sleeve)