ILLUMISITE Planning Application V1.0

GUDID 10884521779990

Planning Software V1.0

Covidien LP

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 10884521779990
• NIH Device Record Key: f603e3a4-c0bf-4f38-a590-15d9d7ea69aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILLUMISITE
• Version Model Number: Planning Application V1.0
• Catalog Number: Planning Application V1.0
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *N
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521779990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191394

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2019-10-21
• Device Publish Date: 2019-10-12

On-Brand Devices [ILLUMISITE]

• 10884521779990: Planning Software V1.0
• 10884521779983: Procedure Software V1.0
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• 10884521723986: Bronchoscope Adapter for use with Pentax bronchoscopes
• 10884521723979: Bronchocope Adapter for use with Olyumpus 190 bronchoscope
• 10884521723962: Bronchoscope Adapter for use with Olympus bronchoscopes
• 10884521723955: Patient Sensor Patch
• 10884521723801: Bronchoscope Adapter for use with Fujinon bronchoscopes
• 10884521723795: Bronchoscope Adapter for use with Pentax bronchoscopes
• 10884521723788: Bronchoscope Adapter for use with Olympus 190 bronchoscopes
• 10884521723771: Bronchoscope Adapter for use with Olympus bronchoscopes
• 10884521723634: Console
• 10884521723832: Endobronchial Procedure Kit 45 Catheter
• 10884521723825: Endobronchial Procedure Kit 90 Catheter
• 10884521723818: Endobronchial Procedure Kit 180 Catheter
• 10884521812383: ILS-1000-CS ILLUMISITE CONSOLE EU
• 20884521807980: Patient Sensor Patches
• 10884521812413: Endobronchial Procedure Kit 45 Catheter
• 20884521842424: Patient Sensor Patches
• 10884521837096: Console
• 10884521842915: Console
• 10884521837157: Console
• 10884521837140: Console
• 10884521837133: Console
• 10884521837126: Console
• 10884521837102: Console