| Primary Device ID | 00812345029673 |
| NIH Device Record Key | b694a1b5-e0a1-44bf-92ff-fdfee67e8a69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AM12M |
| Version Model Number | 41000-037-51 |
| 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 | false |
| Serial Number | true |
| 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 Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812345029673 [Primary] |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| 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 |
| 00812345029710 | Wired Acquisition System cleared with Surveyor S12/S19 Monitor |
| 00812345029673 | Wired Acquisition System cleared with Surveyor S12/S19 Monitor |
| 00812345029666 | Wired Acquisition System cleared with Surveyor S12/S19 Monitor |