Trilogy 200 Ventilator, Intl-Recert U1032800

GUDID 00606959033917

Trilogy 200 Ventilator, Recertified, International version

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959033917
• NIH Device Record Key: fec844db-354e-4c86-b03b-c89602c7f178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trilogy 200 Ventilator, Intl-Recert
• Version Model Number: 00
• Catalog Number: U1032800
• 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
• Phone: +1(724) 387-4000
• Email: respironics.service@philips.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959033917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093416

FDA Product Code

• DQA: Oximeter

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: 2016-09-23

Devices Manufactured by Respironics, Inc.

• 00606959051942 - Trilogy Evo: 2022-05-23 Trilogy Evo, USA
• 00606959417540 - DreamStation: 2022-01-10 Micro-Flexible Heated 12mm Tube
• 00606959060135 - Therapy Mask 3100: 2021-12-16 Medium Wide, Therapy Mask 3100 Silicone
• 00606959060098 - Therapy Mask 3100: 2021-11-04
• 00606959060104 - Therapy Mask 3100: 2021-11-04
• 00606959060128 - Therapy Mask 3100: 2021-11-04
• 00606959063082 - DreamStation 2: 2021-11-04
• 00606959063228 - DreamStation 2: 2021-11-04