Watch-PAT 200i US2150309

GUDID 07290109220031

Watch-PAT200 Device (Recertified)

ITAMAR MEDICAL LTD

Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph

• Primary Device ID: 07290109220031
• NIH Device Record Key: 0c9778c3-6ee0-46c2-a456-a91ff9379549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Watch-PAT 200i
• Version Model Number: Watch-PAT 200i
• Catalog Number: US2150309
• 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: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com
• Phone: +97246177000
• Email: info@itamar-medical.com

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07290109220017 [Package]; Contains: 07290109222608; Package: carton [1 Units]; In Commercial Distribution
GS1	07290109220031 [Package]; Contains: 07290109222608; Package: carton [1 Units]; In Commercial Distribution
GS1	07290109222608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081037

FDA Product Code

• MNR: Ventilatory Effort Recorder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

On-Brand Devices [Watch-PAT 200i]

• 07290109222981: Watch-PAT200 Device
• 07290109222974: Watch-PAT200 Device
• 07290109220031: Watch-PAT200 Device (Recertified)
• 07290109222592: Watch-PAT200 Device