| Primary Device ID | 07290109222424 |
| NIH Device Record Key | a468e373-125b-4a52-a097-416844d4db05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WatchPATONE |
| Version Model Number | WatchPATONE |
| Catalog Number | AC2110800 |
| 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 | true |
| Lot Batch | false |
| 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 |
| Phone | +97246177000 |
| info@itamar-medical.com | |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
| Storage 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 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290109222264 [Package] Contains: 07290109222431 Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222271 [Package] Contains: 07290109222431 Package: [1 Units] In Commercial Distribution |
| GS1 | 07290109222424 [Primary] |
| GS1 | 07290109222431 [Package] Package: carton [12 Units] In Commercial Distribution |
| GS1 | 07290109223360 [Package] Package: carton [48 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 | 4 |
| Public Version Date | 2020-05-13 |
| Device Publish Date | 2019-06-30 |
| 07290109225227 - Accessories, EndoPATx | 2023-05-05 Accessories for EndoPATx |
| 07290109225425 - EndoPATx | 2023-05-05 EndoPATx Device |
| 07290109223377 - EndoPATx | 2023-05-05 EndoPATx Device |
| 07290109223193 - Central Plus Sensor | 2023-03-21 Central Plus Sensor for WatchPAT300 |
| 07290109223223 - WatchPAT ONE | 2023-03-21 WatchPAT ONE-M for Canada |
| 07290109223230 - WatchPAT ONE | 2023-03-21 WatchPAT ONE E for Canada |
| 07290109223254 - WatchPAT ONE | 2023-03-21 WatchPAT ONE for Canada |
| 07290109222103 - 12 uPAT Probes for Watch-PAT | 2023-03-14 12 uPAT Probes |