CORVITALS
GUDID B353CV12452
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
LIFESIGNALS, INC.
Electrocardiography telemetric monitoring system| Primary Device ID | B353CV12452 |
| NIH Device Record Key | 4d1880a9-c0e2-4f11-ac9b-8cddcf28c531 |
| Commercial Distribution Discontinuation | 2021-06-30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CORVITALS |
| Version Model Number | CV1245 |
| Company DUNS | 798830720 |
| Company Name | LIFESIGNALS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B353CV12451 [Primary] |
| HIBCC | B353CV12452 [Package] Contains: B353CV12451 Package: Box [25 Units] Discontinued: 2021-06-30 In Commercial Distribution |
| HIBCC | B353CV12453 [Package] Package: Large Box [8 Units] Discontinued: 2021-06-30 In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172011
FDA Product Code
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-06 |
| Device Publish Date | 2020-06-26 |
On-Brand Devices [CORVITALS]
| B353CV12452 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch |
| B353CV12532 | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch |
Trademark Results [CORVITALS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORVITALS 87032710 5381433 Live/Registered |
Both, John 2016-05-11 |
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