Home GUDID B353CS124502 Cherish Serenity
Primary DI B353CS124502
Brand Cherish Serenity
Company LIFESIGNALS, INC.
Model CS1245
Device description Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Published 2020-05-20
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B353CS124502 Package HIBCC 25 Not in Commercial Distribution B353CS124503 Package HIBCC 8 Not in Commercial Distribution B353CS124501 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Electrocardiography telemetric monitoring system An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 0 Degrees Celsius 40 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 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 40 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. DRT 2026-05-27 B3944670047010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945000030010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945300046010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945300054010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945300054020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945600013020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048030 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048040 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048050 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048060 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048070 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048080 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048090 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700048100 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700051020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700063010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700064010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 B3945700068020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRT 2026-05-27 00840682147811 CARESCAPE Software GE Healthcare Finland Oy DRT 2026-04-15 08809988780049 Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E) Xandar Kardian Korea Inc. DRT 2025-12-04 00850005949671 BioButton Charging Station BIOINTELLISENSE, INC. DRT 2025-11-19 00856298006343 Aermos software ScottCare Cardiovascular Solutions DRT 2025-10-28 00856298006381 Aermos Tx Device ScottCare Cardiovascular Solutions DRT 2025-10-28 00856298006411 Aermos SCOTTCARE CORPORATION, THE DRT 2025-10-28 00856298006442 Aermos Tx Patiet Cable ScottCare Cardiovascular Solutions DRT 2025-10-28 00850005949466 BioDashboard BIOINTELLISENSE, INC. DRT 2025-02-28 00850005949596 BioButton Charging Station BIOINTELLISENSE, INC. DRT 2025-02-19
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