| Primary Device ID | B353LA1252R1 |
| NIH Device Record Key | 61eeb35b-e9d7-4dfb-9351-b72269ab3640 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HOLTER CONNECT |
| Version Model Number | LA1252R |
| Company DUNS | 798830720 |
| Company Name | LIFESIGNALS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B353LA1252R1 [Primary] |
| 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 | 2021-11-23 |
| Device Publish Date | 2021-11-15 |
| B353LA1252R1 | HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially av |
| B353LA1252C1 | HOLTER CONNECT business logic is a software running on cloud platform that provides interface fo |