Trilogy EV300 FX2200X15B

GUDID 00606959061033

Trilogy EV300, Intl

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959061033
• NIH Device Record Key: cf31a951-96a6-4833-acb8-1d4f38220859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trilogy EV300
• Version Model Number: FX2200X15B
• Catalog Number: FX2200X15B
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959061033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181166

FDA Product Code

• NOU: Continuous, ventilator, home 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: 2020-07-29
• Device Publish Date: 2020-07-21

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