Trilogy

FDA UDI

Class I (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: Trilogy FDA UDI
Generic Name: Portable electric ventilator FDA UDI
Device Name: Trilogy 200 Ventilator with Bluetooth, Rental, USA FDA UDI
Model / Reference: RTO1040005B FDA UDI
Description: Trilogy 200 Ventilator with Bluetooth, Rental, USA FDA UDI

Identifiers

Catalog Number: RTO1040005B FDA UDI
Primary DI / UDI-DI: 00606959038875 FDA UDI
510(k) Number: K093416 FDA UDI
FDA Product Code: OUG FDA UDI
DQA FDA UDI
CBK FDA UDI
GMDN Term: Portable electric ventilator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6310 FDA UDI
870.2700 FDA UDI
868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Portable electric ventilator

Trilogy by Respironics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K093416 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Respironics, Inc.

Sources (1)

FDA UDI f7b608d1-845e-403d-b847-def8cc391fff 37 fields · synced Jun 8, 2026