DEVICE: Trilogy 200 Ventilator, Aeris 200, Bluetooth (00606959027763)

Device Identifier (DI) Information

Trilogy 200 Ventilator, Aeris 200, Bluetooth
00
In Commercial Distribution
1125564B
Respironics, Inc.
00606959027763
GS1
December 31, 9999
1
080728314 *Terms of Use
Trilogy 200 Ventilator (Aeris 200 model) with Bluetooth
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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).
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K093416 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4a6eb7a0-016a-4f4b-af11-b5f39cd4f342
July 06, 2018
4
September 07, 2016
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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
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1 724-387-4000
Respironics.Service@Philips.com
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