| Primary Device ID | 00606959055483 | 
| NIH Device Record Key | ff2db2f4-4850-4a80-9a1d-4df9cba515ab | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Trilogy Evo | 
| Version Model Number | KR2110X15B | 
| Catalog Number | KR2110X15B | 
| Company DUNS | 080728314 | 
| Company Name | Respironics, Inc. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00606959055483 [Primary] | 
| CBK | Ventilator, continuous, facility use | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-02-22 | 
| Device Publish Date | 2021-02-12 | 
| 30606959054517 | Disposable Swivel Passive Exhalation Port | 
| 00606959054103 | Trilogy Evo Ventilator system with oxygen blending module, Germany | 
| 00606959051959 | Trilogy Evo Ventilator system, international | 
| 00606959054042 | Trilogy Evo, O2, Postponement | 
| 00606959054035 | Trilogy Evo Ventilator system, postponement | 
| 00606959051997 | Trilogy Evo Ventilator system with oxygen blending module, Domestic | 
| 00606959052314 | Trilogy Evo Ventilator with Oxygen Blending Module, Canada | 
| 00606959052307 | Trilogy Evo Ventilator, Canada | 
| 00606959055636 | Trilogy Evo Ventilator with Oxygen Blending Module, India | 
| 00606959055698 | Trilogy Evo O2, Eastern Europe | 
| 00606959055681 | Trilogy Evo, O2, EU (Non-BT) | 
| 00606959055650 | Trilogy Evo, O2, Nordics | 
| 00606959055551 | Trilogy Evo Ventilator system, Turkey | 
| 00606959055544 | Trilogy Evo, Eastern Europe | 
| 00606959055537 | Trilogy Evo, EU (non-BT) | 
| 00606959055513 | Trilogy Evo, Nordics | 
| 00606959055506 | Trilogy Evo, France | 
| 00606959054134 | Trilogy Evo, O2, Great Britain | 
| 00606959054127 | Trilogy Evo Ventilator system, Great Britian | 
| 00606959061026 | Trilogy Evo, International | 
| 00606959061019 | Trilogy Evo, O2, International | 
| 00606959055667 | Trilogy Evo, O2, Benelux | 
| 00606959055520 | Trilogy Evo Ventilator System, Benelux | 
| 00606959051980 | Trilogy Evo Ventilator system, Australia | 
| 00606959055483 | Trilogy Evo Ventilator system, Korea | 
| 00606959051942 | Trilogy Evo, USA | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TRILOGY EVO  79231179  5663637 Live/Registered | Koninklijke Philips N.V. 2018-03-12 |