DEVICE: Trilogy (00606959026162)

Device Identifier (DI) Information

Trilogy
00
In Commercial Distribution
1052127
Respironics, Inc.
00606959026162
GS1
December 31, 9999
1
080728314 *Terms of Use
Trilogy Ventilator Passive Exhalation Circuit, Pediatric circuit
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Ventilator breathing circuit, reusable A non-sterile assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CBK VENTILATOR, CONTINUOUS, FACILITY USE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K083526 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

24f961b6-083b-48ee-af9a-b8f3dda49de0
July 06, 2018
4
October 23, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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