← Back to catalogue

WVSM Wireless Vital Signs Monitor

FDA UDI

Class II (US FDA UDI)

by Athena Gtx

Identity

Trade Name
WVSM Wireless Vital Signs Monitor FDA UDI
Generic Name
Electrocardiographic lead set, single-use FDA UDI
Device Name
ECG Lead Wires - Bonded FDA UDI
Model / Reference
ECG Cables FDA UDI
Description
ECG Lead Wires - Bonded FDA UDI

Identifiers

Catalog Number
570-0004-02 FDA UDI
Primary DI / UDI-DI
B3945700004020 FDA UDI
FDA Product Code
MWI FDA UDI
DQA FDA UDI
DRG FDA UDI
DXN FDA UDI
GMDN Term
Electrocardiographic lead set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
870.2700 FDA UDI
870.2910 FDA UDI
870.1130 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiographic lead set, single-use

WVSM Wireless Vital Signs Monitor by Athena Gtx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Athena Gtx

Sources (1)

  • FDA UDI 267d0057-b555-4fe5-b9bb-cb697f22e0ec 35 fields · synced Jun 6, 2026