Trilogy Evo DS2100X11B

GUDID 00606959051997

Trilogy Evo Ventilator system with oxygen blending module, Domestic

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959051997
• NIH Device Record Key: 970bac37-05f1-499d-a139-6c302e784430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trilogy Evo
• Version Model Number: DS2100X11B
• Catalog Number: DS2100X11B
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959051997 [Primary]

FDA Product Code

• DQA: Oximeter

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: 2019-09-13
• Device Publish Date: 2019-09-05

On-Brand Devices [Trilogy Evo]

• 30606959054517: Disposable Swivel Passive Exhalation Port
• 00606959054103: Trilogy Evo Ventilator system with oxygen blending module, Germany
• 00606959051959: Trilogy Evo Ventilator system, international
• 00606959054042: Trilogy Evo, O2, Postponement
• 00606959054035: Trilogy Evo Ventilator system, postponement
• 00606959051997: Trilogy Evo Ventilator system with oxygen blending module, Domestic
• 00606959052314: Trilogy Evo Ventilator with Oxygen Blending Module, Canada
• 00606959052307: Trilogy Evo Ventilator, Canada
• 00606959055636: Trilogy Evo Ventilator with Oxygen Blending Module, India
• 00606959055698: Trilogy Evo O2, Eastern Europe
• 00606959055681: Trilogy Evo, O2, EU (Non-BT)
• 00606959055650: Trilogy Evo, O2, Nordics
• 00606959055551: Trilogy Evo Ventilator system, Turkey
• 00606959055544: Trilogy Evo, Eastern Europe
• 00606959055537: Trilogy Evo, EU (non-BT)
• 00606959055513: Trilogy Evo, Nordics
• 00606959055506: Trilogy Evo, France
• 00606959054134: Trilogy Evo, O2, Great Britain
• 00606959054127: Trilogy Evo Ventilator system, Great Britian
• 00606959061026: Trilogy Evo, International
• 00606959061019: Trilogy Evo, O2, International
• 00606959055667: Trilogy Evo, O2, Benelux
• 00606959055520: Trilogy Evo Ventilator System, Benelux
• 00606959051980: Trilogy Evo Ventilator system, Australia
• 00606959055483: Trilogy Evo Ventilator system, Korea
• 00606959051942: Trilogy Evo, USA