HFVi monitor - HFVI Monitor is intended for use in a medical - MDOLORIS MEDICAL SYSTEMS

Duns Number:262207287

Device Description: HFVI Monitor is intended for use in a medical environment and under the direct supervision HFVI Monitor is intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The system is intended for use on adult and pediatric patients, in a facility providing patient care by monitoring heart rate variability.The High Frequency Variability Index (HFVI) is a complex monitoring technology intended for use as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the HFVI in conjunction with other available clinical signs. As with any monitored parameter, artifacts and poor signal quality may lead to inappropriate HFVI values. Potential artifacts may be caused by muscle activity or rigidity, patient motion, improper sensor placement or electrical interference.

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


More Product Details

Catalog Number

-

Brand Name

HFVi monitor

Version/Model Number

V1

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DPS

Product Code Name

Electrocardiograph

Device Record Status

Public Device Record Key

dc24db38-a54a-45a5-a786-4112344808d1

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

December 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MDOLORIS MEDICAL SYSTEMS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4