Home GUDID B353UB22511 UbiqVue Holter
Primary DI B353UB22511
Brand UbiqVue Holter
Company Lifesignals, Inc.
Model UB2251
Device description 2AYe Wearable Biosensor
Published 2025-04-22
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 DXH Transmitters And Receivers, Electrocardiograph, Telephone MWJ Electrocardiograph, Ambulatory (Without Analysis)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular 2 DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular 2 MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B353UB22512 Package HIBCC 25 In Commercial Distribution B353UB22513 Package HIBCC 4 In Commercial Distribution B353UB22511 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 5 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 06975817741016 DMS 300-3A Holter Recorder Dm Systems (Beijing) Co., Ltd. MWJ 2026-07-22 06975817741023 DMS 300-4AL Holter Recorder Dm Systems (Beijing) Co., Ltd. MWJ 2026-07-22 06975817741047 DMS 300-4A Holter Recorder Dm Systems (Beijing) Co., Ltd. MWJ 2026-07-22 06975817741054 DMS 300-2W Holter Recorder Dm Systems (Beijing) Co., Ltd. MWJ 2026-07-22 B353UB25511 UbiqVue Multiparameter Lifesignals, Inc. DRG 2026-07-20 00850048674028 HeartBeam ECG System HeartBeam, Inc. DXH 2026-07-16 00850048674028 HeartBeam ECG System HeartBeam, Inc. MWJ 2026-07-16 00850086928008 SENSINEL™ CPM BASE STATION Analog Devices, Inc. DXH 2026-06-03 00850086928015 SENSINEL™ CPM WEARABLE Analog Devices, Inc. DXH 2026-06-03 00850086928022 SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) Analog Devices, Inc. DXH 2026-06-03 00850086928039 SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) Analog Devices, Inc. DXH 2026-06-03 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
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