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Hfvi Sensor V1

FDA UDI

Class II (US FDA UDI)

by Mdoloris Medical Systems

Identity

Trade Name
HFVI SENSOR V1 FDA UDI
Generic Name
Electrocardiographic electrode, single-use FDA UDI
Device Name
The HFVI sensor is a disposable, pre-gelled 3-lead array. The HFVI sensor is to be usd with the HFVI Pain Monitoring System and may be worn for a continous period of 24 hours in a hospital environment. FDA UDI
Model / Reference
V1 FDA UDI
Description
The HFVI sensor is a disposable, pre-gelled 3-lead array. The HFVI sensor is to be usd with the HFVI Pain Monitoring System and may be worn for a continous period of 24 hours in a hospital environment. FDA UDI

Identifiers

Primary DI / UDI-DI
03760232460245 FDA UDI
FDA Product Code
DRX FDA UDI
GMDN Term
Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic electrode, single-use

Hfvi Sensor V1 by Mdoloris Medical Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic electrode, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mdoloris Medical Systems

Sources (1)

  • FDA UDI 7b483267-6cd3-4d2f-84c3-5ed131809aa2 33 fields · synced May 30, 2026