Trilogy Evo KR2110X15B

GUDID 00606959055483

Trilogy Evo Ventilator system, Korea

Respironics, Inc.

Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator
Primary Device ID00606959055483
NIH Device Record Keyff2db2f4-4850-4a80-9a1d-4df9cba515ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrilogy Evo
Version Model NumberKR2110X15B
Catalog NumberKR2110X15B
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]
GS100606959055483 [Primary]

FDA Product Code

CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use
CBKVentilator, continuous, facility use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-12

On-Brand Devices [Trilogy Evo]

30606959054517Disposable Swivel Passive Exhalation Port
00606959054103Trilogy Evo Ventilator system with oxygen blending module, Germany
00606959051959Trilogy Evo Ventilator system, international
00606959054042Trilogy Evo, O2, Postponement
00606959054035Trilogy Evo Ventilator system, postponement
00606959051997Trilogy Evo Ventilator system with oxygen blending module, Domestic
00606959052314Trilogy Evo Ventilator with Oxygen Blending Module, Canada
00606959052307Trilogy Evo Ventilator, Canada
00606959055636Trilogy Evo Ventilator with Oxygen Blending Module, India
00606959055698Trilogy Evo O2, Eastern Europe
00606959055681Trilogy Evo, O2, EU (Non-BT)
00606959055650Trilogy Evo, O2, Nordics
00606959055551Trilogy Evo Ventilator system, Turkey
00606959055544Trilogy Evo, Eastern Europe
00606959055537Trilogy Evo, EU (non-BT)
00606959055513Trilogy Evo, Nordics
00606959055506Trilogy Evo, France
00606959054134Trilogy Evo, O2, Great Britain
00606959054127Trilogy Evo Ventilator system, Great Britian
00606959061026Trilogy Evo, International
00606959061019Trilogy Evo, O2, International
00606959055667Trilogy Evo, O2, Benelux
00606959055520Trilogy Evo Ventilator System, Benelux
00606959051980Trilogy Evo Ventilator system, Australia
00606959055483Trilogy Evo Ventilator system, Korea

Trademark Results [Trilogy Evo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRILOGY EVO
TRILOGY EVO
79231179 5663637 Live/Registered
Koninklijke Philips N.V.
2018-03-12

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