Vectraplex CMS - Vectraplex Central Monitoring System - VECTRACOR INC

Duns Number:828416359

Device Description: Vectraplex Central Monitoring System

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


More Product Details

Catalog Number

-

Brand Name

Vectraplex CMS

Version/Model Number

V100705

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140852

Product Code Details

Product Code

MHX

Product Code Name

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

Device Record Status

Public Device Record Key

cf38e516-9d31-492a-90f2-d6da60b826da

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VECTRACOR INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5