| Primary Device ID | 00812345025446 |
| NIH Device Record Key | ca940e21-931e-43d4-b1c0-08cde0f2457c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patient Cable Lead Set |
| Version Model Number | 9293-046-63 |
| 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 | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812345025446 [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 |
| 00812345025767 | Leadwire set cleared with ELI 380 |
| 00812345025750 | Leadwire set cleared with ELI 380 |
| 00812345025743 | Leadwire set cleared with ELI 380 |
| 00812345025736 | Leadwire set cleared with ELI 380 |
| 00812345025729 | Leadwire set cleared with ELI 380 |
| 00812345025712 | Leadwire set cleared with ELI 380 |
| 00812345025705 | Patient cable cleared with XScribe Stress System |
| 00812345025682 | Patient cable cleared with ELI 380 |
| 00812345025668 | Patient cable cleared with ELI 380 |
| 00812345025644 | Patient cable cleared with ELI 380 |
| 00812345025620 | Patient cable cleared with ELI 380 |
| 00812345025606 | Patient cable cleared with ELI 380 |
| 00812345025590 | Patient cable cleared with ELI 380 |
| 00812345025583 | Patient cable cleared with ELI 380 |
| 00812345025576 | Patient cable cleared with ELI 380 |
| 00812345025569 | Leadwire set cleared with ELI 280 |
| 00812345025552 | Leadwire set cleared with ELI 280 |
| 00812345025545 | Leadwire set cleared with ELI 280 |
| 00812345025538 | Leadwire set cleared with ELI 280 |
| 00812345025521 | Leadwire set cleared with ELI 280 |
| 00812345025514 | Leadwire set cleared with ELI 280 |
| 00812345025507 | Leadwire set cleared with ELI 280 |
| 00812345025491 | Leadwire set cleared with ELI 280 |
| 00812345025484 | Leadwire set cleared with ELI 280 |
| 00812345025460 | Leadwire set cleared with ELI 280 |
| 00812345025446 | Leadwire set cleared with ELI 280 |
| 00812345025422 | Leadwire set cleared with ELI 280 |
| 00812345025347 | Patient cable cleared with ELI 350 |
| 00812345025323 | Patient cable cleared with ELI 350 |
| 00812345025309 | Patient cable cleared with ELI 350 |
| 00812345025286 | Patient cable cleared with ELI 350 |
| 00812345025248 | Patient cable cleared with ELI 350 |
| 00812345025224 | Patient cable cleared with ELI 350 |
| 00812345025200 | Patient cable cleared with ELI 350 |
| 00812345025187 | Patient cable cleared with ELI 350 |
| 00812345025163 | Patient cable cleared with ELI 350 |
| 00812345025149 | Patient cable cleared with ELI 350 |
| 00812345022766 | Patient cable cleared with XScribe Stress System |
| 00812345022025 | Patient cable cleared with ELI 380 |
| 00812345022018 | Patient cable cleared with ELI 380 |
| 00812345022001 | Patient cable cleared with ELI 380 |
| 00812345021998 | Patient cable cleared with ELI 380 |
| 00812345021981 | Leadwire set cleared with ELI 280 |
| 00812345021974 | Leadwire set cleared with ELI 280 |
| 00812345021967 | Leadwire set cleared with ELI 280 |
| 00812345021950 | Leadwire set cleared with ELI 280 |
| 00812345021943 | Patient cable cleared with ELI 350 |
| 00812345021936 | Patient cable cleared with ELI 350 |
| 00812345021929 | Patient cable cleared with ELI 350 |
| 00812345021912 | Patient cable cleared with ELI 350 |