FDA.reportPublic FDA data

Cherish Serenity

Primary DI
B353CS124501
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DRXElectrode, ElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172011000LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.2018-06-14DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B353CS124502PackageHIBCC25Not in Commercial Distribution
B353CS124503PackageHIBCC8Not in Commercial Distribution
B353CS124501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn 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
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
510.770.6412saravanan@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
B353CV12531CorVitalsCV1253CV1253_US2021-05-14
B353UB12511UbiqVue HolterUB12512025-04-22
B353UB22511UbiqVue HolterUB22512025-04-22
B353UA2251C1UbiqVue UA2251-C2025-04-22
B353UA2251DA1UbiqVue UA2251-DA2025-04-22
B353UA2251R1UbiqVue UA2251-R2025-04-22
B353UA2251S1UbiqVue UA2251-S2025-04-22
B353UA2251SA1UbiqVue UA2251-SA2025-04-22
B353UA2251W1UbiqVue UA2251-W2025-04-22
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
B353UA2550S1UbiqVue UA2550-S2024-05-15
B353UA2550R1UbiqVue UA2550-R2024-05-06
B353UB15501UbiqVue MultiparameterUB15502024-05-06

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Primary DI, Brand, Company table
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B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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