FDA.reportPublic FDA data

Trilogy Evo, Japan

Primary DI
00606959051973
Brand
Trilogy Evo, Japan
Company
Respironics, Inc.
Model
JP2110X16B
Catalog number
JP2110X16B
Device description
Trilogy Evo, Japan
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NOUContinuous, ventilator, home use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOUContinuous, Ventilator, Home UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959051973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959051973006069590519736069590519730606959051973

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080728314
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959055735Sleepware G3 Sleepware G3 2026-01-22
00606959060586Care OrchestratorCare Orchestrator2026-01-22
00606959424852DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H tube w/Cell,AUX900T15C2017-02-01
00606959424944DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell,AUX1131H15C2017-02-10
00606959424951DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Cell, AUAUX1131S15C2017-02-10
00606959424968DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/CeAUX1131T15C2017-02-10
00606959424975DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi,AUX1131H15W2017-02-10
00606959424982DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/WiFi, AUAUX1131S15W2017-02-10
00606959424999DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WAUX1131T15W2017-02-10
00606959425378DreamStation01CNX1130T172019-12-29
00606959425385DreamStation01CNX1131H172019-12-29
00606959425392DreamStation01CNX1131S172019-12-29
00606959425408DreamStation01CNX1131T172019-11-20
00606959425484DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/CellCAX900T12C2017-02-01
00606959425491DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFiCAX900T12W2017-02-01
00606959425538DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CACAX1130H12C2017-02-10
00606959425545DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Cell, CACAX1130S12C2017-02-10
00606959425552DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humid w/H Tube w/CellCAX1130T12C2017-02-10
00606959425569DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CACAX1130H12W2017-02-10
00606959425576DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/WiFi, CACAX1130S12W2017-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761978089Life2000WELCH ALLYN, INC.NOU2024-05-09
00887761978201Life2000HILL-ROM SERVICES PTE. LTD.NOU2023-01-06
07321820048915Vivo 50Breas Medical ABNOU2022-06-18
07321820048922Vivo 50Breas Medical ABNOU2022-06-18
07321820048939Vivo 50Breas Medical ABNOU2022-06-18
07321820048946Vivo 50Breas Medical ABNOU2022-06-18
07321820048960Vivo 50Breas Medical ABNOU2022-06-18
07321820048977Vivo 50Breas Medical ABNOU2022-06-18
07321820048984Vivo 50Breas Medical ABNOU2022-06-18
07321820050369Vivo 50Breas Medical ABNOU2022-06-18
07321820050949Vivo 50Breas Medical ABNOU2022-06-18
07321820052233Vivo 50Breas Medical ABNOU2022-06-18
07321820054282Vivo 50Breas Medical ABNOU2022-06-18
07321820054299Vivo 50Breas Medical ABNOU2022-06-18
07321820059287Vivo 50Breas Medical ABNOU2022-06-18
07321820072194Vivo 50Breas Medical ABNOU2022-06-18
00606959062962Aeris EvoRespironics, Inc.NOU2021-03-19
00606959044203Care OrchestratorRespironics, Inc.NOU2020-09-23
00606959052017Trilogy EV300, USARespironics, Inc.NOU2020-08-31
00606959057456LifeVent EVO2Respironics, Inc.NOU2020-08-31
00855573007938VOCSN Patient Breathing PackageVENTEC LIFE SYSTEMS, INC.NOU2020-07-22
00606959061019Trilogy EvoRespironics, Inc.NOU2020-07-21
00606959061026Trilogy EvoRespironics, Inc.NOU2020-07-21
00606959061033Trilogy EV300Respironics, Inc.NOU2020-07-21
00606959054127Trilogy EvoRespironics, Inc.NOU2020-06-26
00606959055513Trilogy EvoRespironics, Inc.NOU2020-06-26
00606959055537Trilogy EvoRespironics, Inc.NOU2020-06-26
00606959055544Trilogy EvoRespironics, Inc.NOU2020-06-26
00606959055698Trilogy EvoRespironics, Inc.NOU2020-06-26
00606959055704Trilogy Evo, O2Respironics, Inc.NOU2020-06-26