Home GUDID 00843997016018 Radius VSM
Primary DI 00843997016018
Brand Radius VSM
Company MASIMO CORPORATION
Model 4695
Device description Radius VSM ECG Electrode Set Adult 3-Lead Set
Published 2026-02-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DPS Electrocardiograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DPS Electrocardiograph Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10843997016015 Primary GS1 0 00843997016018 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10843997016015 10843997016015 00843997016018 00843997016018 843997016018 0843997016018
GMDN Terms# Term, Definition table Term Definition Electrocardiographic electrode, single-use A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 0 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature -40 Degrees Celsius 35 Degrees Celsius Storage Environment Humidity 0 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 780421038 Device count 20 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B3944060056010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3944670047010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945000030010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945300046010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945300054010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945300054020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945600013020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048030 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048040 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048050 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048060 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048070 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048080 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048090 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700048100 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700051020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700063010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700064010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 B3945700068020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DPS 2026-05-27 00810209880019 CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response Pink Eko Devices, Inc. DPS 2026-04-03 00810209880026 CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy Eko Devices, Inc. DPS 2026-04-03 00195278620873 MAC Ge Medical Systems Information Technologies, Inc. DPS 2026-03-31 10843997011003 Radius VSM MASIMO CORPORATION DPS 2026-02-23 10843997016015 Radius VSM MASIMO CORPORATION DPS 2026-02-23 00810209880002 CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue Eko Devices, Inc. DPS 2026-01-29 00810209880040 EFAST (Eko Foundation Analysis Software with Transformers) Eko Devices, Inc. DPS 2026-01-29 14250892908509 Jaeger Jaeger Medical GmbH DPS 2025-11-24 14250892908936 Jaeger Jaeger Medical GmbH DPS 2025-11-24
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