| Primary Device ID | 03760232460184 |
| NIH Device Record Key | 2442356b-42db-41aa-8184-9db0fcf64be5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BA-HFVI-V1 |
| Version Model Number | V1 |
| Company DUNS | 262207287 |
| Company Name | MDOLORIS MEDICAL SYSTEMS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760232460184 [Primary] |
| DPS | Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-03-10 |
| Device Publish Date | 2019-01-10 |
| 03760232460283 - HFVI-SC-V1 | 2024-06-06 The patient cable is used to connect the HFVI Sensor (UDI number 03760232460245) to the acquisition box BA-HFVI-V1 (UDI number 0 |
| 03760232460177 - HFVi monitor | 2021-03-10 HFVI Monitor is intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner |
| 03760232460184 - BA-HFVI-V1 | 2021-03-10The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI number : 03760232460177) |
| 03760232460184 - BA-HFVI-V1 | 2021-03-10 The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI number : 03760232460177) |