| Primary Device ID | 07290109222462 |
| NIH Device Record Key | 5b3c92b9-0d9a-4af9-b7f2-93ec535ced27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Watch-PAT300 |
| Version Model Number | Watch-PAT300 |
| Catalog Number | AS2110701 |
| Company DUNS | 531857076 |
| Company Name | ITAMAR MEDICAL LTD |
| 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 |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| Phone | +97246177000 |
| info@itamar-medical.com |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290109222141 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222158 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222165 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222172 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222226 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222233 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222240 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222257 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222455 [Primary] |
| GS1 | 07290109222462 [Package] Contains: 07290109222455 Package: carton [1 Units] In Commercial Distribution |
| GS1 | 07290109222554 [Package] Package: carton [15 Units] In Commercial Distribution |
| MNR | Ventilatory Effort Recorder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-06 |
| Device Publish Date | 2019-06-30 |
| 07290109222417 | Watch-PAT300 Device |
| 07290109222462 | Watch-PAT300 Device |
| 07290109222486 | Watch-PAT300 Device |