WatchPAT400 AS2110900

GUDID 07290109223575

WatchPAT400 Device

ITAMAR MEDICAL LTD

Polysomnograph

• Primary Device ID: 07290109223575
• NIH Device Record Key: 558a06c9-d1ac-4c4d-a715-8df500273997
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WatchPAT400
• Version Model Number: WatchPAT400
• Catalog Number: AS2110900
• 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

Customer Support Contacts

• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com
• Phone: 1-888-748-2627
• Email: itamar-support@zoll.com

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07290109223568 [Primary]
GS1	07290109223575 [Package]; Contains: 07290109223568; Package: carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250460

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2025-12-09
• Device Publish Date: 2025-12-01

Devices Manufactured by ITAMAR MEDICAL LTD

• 07290109223575 - WatchPAT400: 2025-12-09WatchPAT400 Device
• 07290109223575 - WatchPAT400: 2025-12-09 WatchPAT400 Device
• 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