E-Scribe
GUDID 00812345027761
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system| Primary Device ID | 00812345027761 |
| NIH Device Record Key | 9e0f2a6d-8713-4bbb-bde5-9441e9c86a03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E-Scribe |
| Version Model Number | ESCRIBE-CAA-CXACB |
| 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 |
Customer Support Contacts
| 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 | |
| Phone | 888-667-8272 |
| techsupport@mortara.com | |
| Phone | 888-667-8272 |
| techsupport@mortara.com |
Operating and Storage Conditions
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812345027761 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K930558
FDA Product Code
| DPS | Electrocardiograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-29 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [E-Scribe]
| 00812345027785 | Cardiology Data Management System |
| 00812345027778 | Cardiology Data Management System |
| 00812345027761 | Cardiology Data Management System |
| 00812345027754 | Cardiology Data Management System |
| 00812345027747 | Cardiology Data Management System |
| 00812345027730 | Cardiology Data Management System |
| 00817655021270 | Cardiology Data Management System |
| 00817655020617 | Cardiology Data Management System |
Trademark Results [E-Scribe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 E-SCRIBE 73672300 1503659 Live/Registered |
MORTARA INSTRUMENT, INC. 1987-07-16 |
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