DEVICE: Trilogy (00606959026292)

Device Identifier (DI) Information

Trilogy
00
In Commercial Distribution
U1054097
Respironics, Inc.
00606959026292
GS1
December 31, 9999
1
080728314 *Terms of Use
Trilogy100 Ventilator, Recertified, German version
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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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).
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FDA Product Code

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Product Code Product Code Name
CBK VENTILATOR, CONTINUOUS, FACILITY USE
NOU CONTINUOUS, VENTILATOR, HOME USE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K083526 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

561b9a9b-797d-4b6c-b8de-c8236d1a4c13
July 06, 2018
4
October 23, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(724) 387-4000
respironics.service@philips.com
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