Home GUDID B353UB22512 UbiqVue Holter
Primary DI B353UB22512
Brand UbiqVue Holter
Company Lifesignals, Inc.
Model UB2251
Device description 2AYe Wearable Biosensor
Published 2025-04-22
Public version status New
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 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 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 downloaded and analysed at a medical facility, typically using a computer with a dedicated software. 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 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 0 Degrees Celsius 45 Degrees Celsius 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 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 45 Degrees Celsius
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 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 00195278990914 Portrait CSSXB Ge Medical Systems Information Technologies, Inc. DRG 2025-12-10 00198953024096 Portrait CVAXB Ge Medical Systems Information Technologies, Inc. DRG 2025-12-10 00198953030981 PORTRAIT HSWXB GE Healthcare Finland Oy DRG 2025-12-10 B353UB12511 UbiqVue Holter Lifesignals, Inc. DRG 2025-04-22 B353UB22511 UbiqVue Holter Lifesignals, Inc. DRG 2025-04-22 B353UA2251DA1 UbiqVue Lifesignals, Inc. DRG 2025-04-22 B353UA2251SA1 UbiqVue Lifesignals, Inc. DRG 2025-04-22 17290020154009 BB-613P Chest-Monitor 40-Unit Multipack BIOBEAT TECHNOLOGIES LTD DRG 2025-03-05 B353UB25501 UbiqVue Multiparameter Lifesignals, Inc. DRG 2024-11-29
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