| Primary Device ID | 00812345029703 |
| NIH Device Record Key | 1af9128a-723c-4b2a-a9f6-d08ee707868e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AM15E |
| Version Model Number | 9293-063-50 |
| 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 | 00812345029703 [Primary] |
| DPS | Electrocardiograph |
| 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 |
| 21081234502471 - Quik-Prep | 2020-07-20 Electrodes |
| 10812345022176 - Clear Choice Adapter | 2020-06-29 ECG Adapter |
| 10812345023050 - Snap Adapter | 2020-06-29 ECG Adapter |
| 20812345024238 - Quick-Trace Multi-purpose ECG electrodes | 2020-06-29 Electrodes |
| 30812345024686 - CardioSens/Ultra II | 2020-06-29 Electrodes |
| 30812345024723 - Resting Tab Type Electrodes | 2020-06-29 Electrodes |
| 20812345024733 - ECG Monitoring Electrodes | 2020-06-29 Electrodes |
| 21081234502474 - Quik-Prep | 2020-06-29 Electrodes |