ImagineMed

GUDID B353IM12103

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch

LIFESIGNALS, INC.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system
Primary Device IDB353IM12103
NIH Device Record Key68c5eb65-8514-4762-8c12-f4ab5c542b8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagineMed
Version Model NumberIM1210
Company DUNS798830720
Company NameLIFESIGNALS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com
Phone510.770.6412
Emailsaravanan@lifesignals.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB353IM12101 [Primary]
HIBCCB353IM12102 [Package]
Contains: B353IM12101
Package: BOX [25 Units]
In Commercial Distribution
HIBCCB353IM12103 [Package]
Contains: B353IM12102
Package: Large box [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-19

Devices Manufactured by LIFESIGNALS, INC.

B353LA1252C1 - HOLTER CONNECT2021-11-23 HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter
B353LA1252R1 - HOLTER CONNECT2021-11-23 HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tabl
B353LP12511 - LifeSignals2021-11-23 Wearable Biosensor - ECG Remote Monitoring Biosensor
B353AB12512 - Advance Biometrix2021-09-03 Wearable Biosensor - ECG Remote Monitoring Biosensor
B353AB12572 - Advance Biometrix2021-09-03 Wearable Biosensor - ECG Remote Monitoring Biosensor
B353MA12512 - MAWI2021-06-15 Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
B353CV12532 - CorVitals2021-05-24 Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
B353LP12532 - LifeSignals2021-02-05 Wearable Biosensor - ECG Remote Monitoring Biosensor Patch

Trademark Results [ImagineMed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMAGINEMED
IMAGINEMED
88098772 not registered Dead/Abandoned
Restorative Care International, LLC
2018-08-30
IMAGINEMED
IMAGINEMED
88098708 not registered Dead/Abandoned
Restorative Care International, LLC
2018-08-30

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