Home GUDID B353LP12531 LifeSignals
Primary DI B353LP12531
Brand LifeSignals
Company Lifesignals, Inc.
Model LP1253
Catalog number LP1253_US
Device description Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Published 2021-01-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DRG Transmitters And Receivers, Physiological Signal, Radiofrequency MWJ Electrocardiograph, Ambulatory (Without Analysis) QYX Outpatient Cardiac Telemetry
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular 2 MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular 2 QYX Outpatient Cardiac Telemetry Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B353LP12532 Package HIBCC 25 In Commercial Distribution B353LP12533 Package HIBCC 8 In Commercial Distribution B353LP12531 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Telemetric electrocardiographic ambulatory recorder An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be wirelessly transmitted and analysed, typically to a remote computer with a dedicated software located at a medical facility. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Special Storage Condition, Specify 0 0 For long-term storage of more than 30 days, maintain between 10 and 27 Degrees Celsius Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 798830720 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 08720256776567 Corsano CardioWatch 287-2 System Corsano Health B.V. DRG 2026-06-02 04719875011016 EZYPRO ECG Recorder SIGKNOW BIOMEDICAL CO., LTD. DRG 2026-06-01 04719875011023 EZYPRO ECG Recorder SIGKNOW BIOMEDICAL CO., LTD. DRG 2026-06-01 04719875011030 EZYPRO ECG Recorder SIGKNOW BIOMEDICAL CO., LTD. DRG 2026-06-01 B3944060056010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3944670047010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945000030010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945300046010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945300054010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945300054020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945600013020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048030 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048040 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048050 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048060 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048070 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048080 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048090 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048100 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700051020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700063010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700064010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700068020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 07640375610041 SmartCardia 7L Platform SmartCardia SA QYX 2026-04-24 07640375610058 SmartCardia 7L Platform SmartCardia SA QYX 2026-04-24 10841522131349 Eclipse Pro SPACELABS HEALTHCARE (WASHINGTON), INC MWJ 2025-10-09 10841522131356 Eclipse Pro SPACELABS HEALTHCARE (WASHINGTON), INC MWJ 2025-10-09 10841522131363 Eclipse Pro SPACELABS HEALTHCARE (WASHINGTON), INC MWJ 2025-10-09
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