CryoVIVE
GUDID 08800073100018
RecensMedical, Inc.
General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 08800073100018 |
| NIH Device Record Key | d13cf500-8e7d-4b1a-b71e-f46d26aa38f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CryoVIVE |
| Version Model Number | RM-DT02W |
| Company DUNS | 694808508 |
| Company Name | RecensMedical, 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 | true |
| 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 |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800073100018 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203481
FDA Product Code
| GEH | Unit, Cryosurgical, Accessories |
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 | 2021-07-05 |
| Device Publish Date | 2021-06-25 |
Devices Manufactured by RecensMedical, Inc.
| 08800073100049 - TargetCool | 2022-12-07 |
| 08800073100018 - CryoVIVE | 2021-07-05 |
| 08800073100018 - CryoVIVE | 2021-07-05 |
Trademark Results [CryoVIVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOVIVE 90166666 not registered Live/Pending |
RecensMedical.Inc. 2020-09-08 |
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