Trilogy Evo Universal DS2000X11B

GUDID 00606959052000

Trilogy Evo Universal Ventilator

Respironics, Inc.

Portable electric ventilator
Primary Device ID00606959052000
NIH Device Record Key9d12d9f4-1959-410e-9035-78506ea10de1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrilogy Evo Universal
Version Model NumberDS2000X11B
Catalog NumberDS2000X11B
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959052000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2020-03-05
Device Publish Date2020-02-26

Devices Manufactured by Respironics, Inc.

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