DEVICE: Trilogy (00606959005150)
Device Identifier (DI) Information
Trilogy
00
In Commercial Distribution
1040007
Respironics, Inc.
00
In Commercial Distribution
1040007
Respironics, Inc.
Trilogy 202 Ventilator, U.S. version
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Portable electric ventilator | A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQA | Oximeter |
CBK | VENTILATOR, CONTINUOUS, FACILITY USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K093905 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9c910491-8308-4d2d-b840-db9049df9a0d
July 06, 2018
4
October 22, 2015
July 06, 2018
4
October 22, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(724) 387-4000
respironics.service@philips.com
respironics.service@philips.com