| Primary Device ID | 00812345024906 |
| NIH Device Record Key | 7ec50b37-cbbe-4317-a706-afbf4c1b7e59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | H12+ Patient Cable |
| Version Model Number | 9293-028-51 |
| Company DUNS | 062046149 |
| Company Name | MORTARA INSTRUMENT, 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 |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 65 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812345024906 [Primary] |
| DSH | Recorder, Magnetic Tape, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-29 |
| Device Publish Date | 2016-09-24 |
| 00812345024906 | Patient cable cleared with H12+ recorder |
| 00812345023060 | Patient cable cleared with H12+ recorder |