Home GUDID B353CV12452 CORVITALS
Primary DI B353CV12452
Brand CORVITALS
Company LIFESIGNALS, INC.
Model CV1245
Device description Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Published 2020-06-26
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 DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) MWJ Electrocardiograph, Ambulatory (Without Analysis)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular 2 MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B353CV12452 Package HIBCC 25 In Commercial Distribution B353CV12453 Package HIBCC 8 In Commercial Distribution B353CV12451 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 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 0 Degrees Celsius 40 Degrees Celsius 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 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 40 Degrees Celsius 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. 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 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 10841522131387 Eclipse Pro SPACELABS HEALTHCARE (WASHINGTON), INC MWJ 2025-10-09 10841522131394 Eclipse Pro SPACELABS HEALTHCARE (WASHINGTON), INC MWJ 2025-10-09 10841522131400 Eclipse Pro SPACELABS HEALTHCARE (WASHINGTON), INC MWJ 2025-10-09 10841522131370 Eclipse Pro SPACELABS HEALTHCARE (WASHINGTON), INC MWJ 2025-10-01
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