Primary Device ID | B353IM12103 |
NIH Device Record Key | 68c5eb65-8514-4762-8c12-f4ab5c542b8b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ImagineMed |
Version Model Number | IM1210 |
Company DUNS | 798830720 |
Company Name | LIFESIGNALS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B353IM12101 [Primary] |
HIBCC | B353IM12102 [Package] Contains: B353IM12101 Package: BOX [25 Units] In Commercial Distribution |
HIBCC | B353IM12103 [Package] Contains: B353IM12102 Package: Large box [8 Units] In Commercial Distribution |
DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-11-19 |
Device Publish Date | 2018-10-19 |
B353LA1252C1 - HOLTER CONNECT | 2021-11-23 HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter |
B353LA1252R1 - HOLTER CONNECT | 2021-11-23 HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tabl |
B353LP12511 - LifeSignals | 2021-11-23 Wearable Biosensor - ECG Remote Monitoring Biosensor |
B353AB12512 - Advance Biometrix | 2021-09-03 Wearable Biosensor - ECG Remote Monitoring Biosensor |
B353AB12572 - Advance Biometrix | 2021-09-03 Wearable Biosensor - ECG Remote Monitoring Biosensor |
B353MA12512 - MAWI | 2021-06-15 Wearable Biosensor - ECG Remote Monitoring Biosensor Patch |
B353CV12532 - CorVitals | 2021-05-24 Wearable Biosensor - ECG Remote Monitoring Biosensor Patch |
B353LP12532 - LifeSignals | 2021-02-05 Wearable Biosensor - ECG Remote Monitoring Biosensor Patch |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMAGINEMED 88098772 not registered Dead/Abandoned |
Restorative Care International, LLC 2018-08-30 |
IMAGINEMED 88098708 not registered Dead/Abandoned |
Restorative Care International, LLC 2018-08-30 |