| Primary Device ID | 07290109222691 |
| NIH Device Record Key | e83d7875-0784-4ab1-99b4-e2fdcd97b373 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Watch-PAT200U |
| Version Model Number | Watch-PAT200U |
| Catalog Number | AS2150501 |
| 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 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com | |
| Phone | +97246177000 |
| infousa@zoll.com |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290109222561 [Package] Contains: 07290109222660 Package: carton [10 Units] |
| GS1 | 07290109222578 [Package] Contains: 07290109222660 Package: carton [15 Units] |
| GS1 | 07290109222585 [Package] Contains: 07290109222660 Package: carton [1 Units] |
| GS1 | 07290109222622 [Package] Package: carton [1 Units] In Commercial Distribution |
| GS1 | 07290109222660 [Package] Package: carton [1 Units] In Commercial Distribution |
| GS1 | 07290109222691 [Primary] |
| GS1 | 07290109222707 [Package] Contains: 07290109222660 Package: carton [2 Units] |
| GS1 | 07290109222714 [Package] Contains: 07290109222660 Package: carton [3 Units] |
| GS1 | 07290109222721 [Package] Contains: 07290109222660 Package: carton [5 Units] |
| GS1 | 07290109222745 [Package] Contains: 07290109222660 Package: carton [10 Units] In Commercial Distribution |
| GS1 | 07290109222752 [Package] Contains: 07290109222660 Package: carton [15 Units] In Commercial Distribution |
| GS1 | 07290109222769 [Package] Contains: 07290109222660 Package: carton [20 Units] In Commercial Distribution |
| GS1 | 07290109222776 [Package] Contains: 07290109222660 Package: carton [30 Units] In Commercial Distribution |
| GS1 | 07290109222783 [Package] Contains: 07290109222660 Package: carton [40 Units] In Commercial Distribution |
| GS1 | 07290109222790 [Package] Contains: 07290109222660 Package: carton [50 Units] In Commercial Distribution |
| GS1 | 07290109222806 [Package] Contains: 07290109222660 Package: carton [60 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 | 2018-07-06 |
| Device Publish Date | 2017-08-09 |
| 07290109222899 | Watch-PAT200U Device (EU) |
| 07290109222844 | Watch-PAT200U Device (EU) |
| 07290109222738 | Watch-PAT200U Device |
| 07290109222691 | Watch-PAT200U Device |
| 07290109222646 | Watch-PAT200U Device |
| 07290109222523 | Watch-PAT200U Device |