FDA.reportPublic FDA data

CorVitals

Primary DI
B353CV12531
Brand
CorVitals
Company
Lifesignals, Inc.
Model
CV1253
Catalog number
CV1253_US
Device description
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Published
2021-05-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B353CV12532PackageHIBCC25Not in Commercial Distribution
B353CV12533PackageHIBCC8Not in Commercial Distribution
B353CV12531PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius
Special Storage Condition, Specify00For long-term storage of more than 30 days, maintain between 10 and 27 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1.631.388.4080lssupport@lifesignals.com

Regulatory Flags#

DUNS number
798830720
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B353UB25511UbiqVue MultiparameterUB25512026-07-20
B353LP12531LifeSignalsLP1253LP1253_US2021-01-28
B353UB12511UbiqVue HolterUB12512025-04-22
B353UB22511UbiqVue HolterUB22512025-04-22
B353UA2251C1UbiqVueUA2251-C2025-04-22
B353UA2251DA1UbiqVueUA2251-DA2025-04-22
B353UA2251R1UbiqVueUA2251-R2025-04-22
B353UA2251S1UbiqVueUA2251-S2025-04-22
B353UA2251SA1UbiqVueUA2251-SA2025-04-22
B353UA2251W1UbiqVueUA2251-W2025-04-22
B353LA1252C1HOLTER CONNECTLA1252C2021-11-15
B353LA1252R1HOLTER CONNECTLA1252R2021-11-15
B353UB12512UbiqVue HolterUB12512025-04-22
B353UB22512UbiqVue HolterUB22512025-04-22
B353UB25501UbiqVue MultiparameterUB25502024-11-29
B353UB25502UbiqVue MultiparameterUB25502024-11-29
B353UA2550BG1UbiqVue UA2550-BG2024-05-15
B353UA2550C1UbiqVue UA2550-C2024-05-15
B353UA2550MR1UbiqVue UA2550-MR2024-05-15
B353UA2550RB1UbiqVue UA2550-RB2024-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838102866Telemetry Monitor 5500Philips Medizin Systeme Böblingen GmbHMHX2026-10-15
06944413809468Connection CableEdan Instruments, Inc.MHX2026-10-15
00860011800613CardioTagCARDIOSENSE, INC.DRG2026-10-14
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMHX2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMHX2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
06975817741030DMS 300-2 Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-09-30
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916632FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916649FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916656FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06975817741016DMS 300-3A Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-07-22
06975817741023DMS 300-4AL Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-07-22
06975817741047DMS 300-4A Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-07-22
06975817741054DMS 300-2W Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-07-22
B353UB25511UbiqVue MultiparameterLifesignals, Inc.MHX2026-07-20
B353UB25511UbiqVue MultiparameterLifesignals, Inc.DRG2026-07-20
04538612151569FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612161049FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17