Identity
- Trade Name
- HFVi monitor FDA UDI
- Generic Name
- Electrocardiograph, professional, single-channel FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- V1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760232460177 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiograph, professional, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiograph, professional, single-channel
HFVi monitor by Mdoloris Medical Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mdoloris Medical Systems
Sources (1)
- FDA UDI dc24db38-a54a-45a5-a786-4112344808d1 35 fields · synced May 31, 2026