HScribe
GUDID 00812345027242
Holter Analysis System
MORTARA INSTRUMENT, INC.
Electrocardiographic long-term ambulatory recording analyser application software| Primary Device ID | 00812345027242 |
| NIH Device Record Key | 4a9adf37-f68f-499c-b1be-4ffc1b848fe6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HScribe |
| Version Model Number | HSCRIBE-5AB-AXXXD |
| 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 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812345027242 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K004017
FDA Product Code
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm |
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 [HScribe]
| 00812345029857 | Holter Analysis System |
| 00812345029840 | Holter Analysis System |
| 00812345029826 | Holter Analysis System |
| 00812345027334 | Holter Analysis System |
| 00812345027280 | Holter Analysis System |
| 00812345027273 | Holter Analysis System |
| 00812345027266 | Holter Analysis System |
| 00812345027259 | Holter Analysis System |
| 00812345027242 | Holter Analysis System |
| 00812345027235 | Holter Analysis System |
| 00812345027228 | Holter Analysis System |
| 00812345027211 | Holter Analysis System |
| 00812345027204 | Holter Analysis System |
| 00812345027198 | Holter Analysis System |
| 00812345027181 | Holter Analysis System |
| 00812345027174 | Holter Analysis System |
| 00812345027167 | Holter Analysis System |
| 00812345027150 | Holter Analysis System |
| 00812345027143 | Holter Analysis System |
| 00812345027136 | Holter Analysis System |
| 00812345027129 | Holter Analysis System |
| 00817655022635 | Holter Analysis System Software |
| 00817655022529 | Holter Analysis System |
| 00817655022512 | Holter Analysis System |
| 00817655022505 | Holter Analysis System |
| 00817655022499 | Holter Analysis System |
| 00817655022482 | Holter Analysis System |
| 00817655022284 | Holter Analysis System |
| 00817655022277 | Holter Analysis System |
| 00817655022260 | Holter Analysis System |
| 00817655022239 | Holter Analysis System |
| 00817655022161 | Holter Analysis System |
| 00817655021904 | Holter Analysis System |
| 00817655021829 | Holter Analysis System |
| 00817655021744 | Holter Analysis System |
| 00817655021461 | Holter Analysis System |
| 00817655021102 | Holter Analysis System |
| 00817655021096 | Holter Analysis System |
| 00817655021089 | Holter Analysis System |
| 00817655021072 | Holter Analysis System |
| 00817655020716 | Holter Analysis System |
| 00817655020655 | Holter Analysis System |
| 00817655020570 | Holter Analysis System |
| 00817655020563 | Holter Analysis System |
| 00817655020426 | Holter Analysis System |
| 00817655020396 | Holter Analysis System |
| 00817655020389 | Holter Analysis System |
| 00817655020372 | Holter Analysis System |
| 00817655020365 | Holter Analysis System |
| 00817655020228 | Holter Analysis System |
Trademark Results [HScribe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HSCRIBE 97885126 not registered Live/Pending |
Welch Allyn, Inc. 2023-04-12 |
 HSCRIBE 74376623 1827359 Live/Registered |
MORTARA INSTRUMENT, INC. 1993-04-08 |
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