TRILOGY U1040007

GUDID 00606959026254

Trilogy 202 Ventilator, Recertified, U.S. version

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959026254
• NIH Device Record Key: 3c278d02-a3f8-4733-a1fd-bd9d49fe0dff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRILOGY
• Version Model Number: 00
• Catalog Number: U1040007
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• 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: false
• 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(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959026254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093905

FDA Product Code

• CBK: VENTILATOR, CONTINUOUS, FACILITY USE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-23

On-Brand Devices [TRILOGY]

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• 00606959022829: Trilogy 200 Ventilator, Latin America version
• 00606959022812: Trilogy 202 Ventilator, China
• 00606959022805: Trilogy 100 Ventilator, Canada
• 00606959022799: Trilogy 202 Ventilator, Canada
• 00606959022782: Trilogy 200 Ventilator, Canada version
• 00606959022775: Trilogy 100 Ventilator, Brazil
• 00606959022751: Trilogy 100 Ventilator, Germany
• 00606959022744: Trilogy 100 Ventilator, International version
• 00606959022737: Trilogy 200 Ventilator
• 00606959022720: Trilogy 202 Ventilator, German Version
• 00606959022706: Trilogy 202 Ventilator, International
• 00606959022690: Trilogy 200 Ventilator, German version
• 00606959022683: Trilogy 200 Ventilator, International
• 00606959022171: Trilogy 100 Ventilator, China version
• 00606959022096: Trilogy 202 Ventilator, Brazil
• 00606959022089: Trilogy 200 Ventilator, Brazil
• 00606959022065: Trilogy O2 Ventilator, South Korea
• 00606959022058: Trilogy EC Ventilator, U.S. version
• 00606959021662: Trilogy 100 Ventilator, Australia version
• 00606959020764: Trilogy Ventilator - Active Exhalation Circuit Kit
• 00606959015364: Trilogy 100 ventilator, U.S. version
• 00606959005396: Trilogy External Battery Cable
• 00606959005389: Trilogy Ventilator - RS232 Serial Communications Cable
• 00606959005228: Trilogy Active Flow Exhalation Circuit, Pediatric
• 00606959005211: Trilogy Ventilator - Active Flow Exhalation Patient Circuit, Adult
• 00606959005150: Trilogy 202 Ventilator, U.S. version
• 00606959043268: Trilogy Ventilator Car DC Power Cable
• 00606959043244: Trilogy RJ9 to 2.5mm 3inch Female Adapter Cable
• 00606959043190: Trilogy Ventilator Nurse Call Alarm Cable - Open, RJ9, RoHS
• 00606959043183: Trilogy Ventilator Nurse Call Alarm Cable - OPEN - RJ9-.25" RoHS
• 00606959043176: Trilogy Ventilator Nurse Call Alarm Cable - Closed, RJ9-.25", RoHS
• 00606959043169: Trilogy Ventilator Active Positive Airway Pressure (PAP) Tubing Port Adapter
• 00606959043145: Trilogy Ventilator In-Use Device Bag
• 00606959043046: Trilogy Ventilator Oximetry Interface Kit (allows the collection of oximetry data while on thera
• 30606959043023: Trilogy Ventilator - Disposable Patient Circuit
• 00606959042063: Trilogy Ventilator Support System Kit
• 00606959026322: Trilogy100 Ventilator, Rental, U.S. version
• 00606959026315: Trilogy100 Ventilator, U.S. Recertified unit
• 00606959026308: Trilogy100 Ventilator, U.S. Rental unit
• 00606959026292: Trilogy100 Ventilator, Recertified, German version
• 00606959026285: Trilogy100 Ventilator, Rental, German version
• 00606959026278: Trilogy100 Ventilator Recertified, International version
• 00606959026261: Trilogy100 Ventilator, Rental, International version
• 00606959026254: Trilogy 202 Ventilator, Recertified, U.S. version
• 00606959026247: Trilogy 202 Ventilator, U.S.Rental unit
• 00606959026230: Trilogy 200 Ventilator Recertified, U.S. version
• 00606959026223: Trilogy 200 Ventilator, Rental, U.S. version
• 00606959026162: Trilogy Ventilator Passive Exhalation Circuit, Pediatric circuit