Trilogy Evo Universal DS2000X11B

GUDID 00606959052000

Trilogy Evo Universal Ventilator

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959052000
• NIH Device Record Key: 9d12d9f4-1959-410e-9035-78506ea10de1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trilogy Evo Universal
• Version Model Number: DS2000X11B
• Catalog Number: DS2000X11B
• 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	00606959052000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181170

FDA Product Code

• CBK: Ventilator, continuous, facility use

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: 2020-03-05
• Device Publish Date: 2020-02-26

Devices Manufactured by Respironics, Inc.

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• 00606959060104 - Therapy Mask 3100: 2021-11-04
• 00606959060128 - Therapy Mask 3100: 2021-11-04
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• 00606959063228 - DreamStation 2: 2021-11-04