Duns Number:080728314
Device Description: Trilogy Evo Ventilator System with Oxygen Blending Module, Iberia Spain
Catalog Number
ES2100X15B
Brand Name
Trilogy
Version/Model Number
Trilogy Evo Ventilator with oxygen blending model, Iberia
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBK
Product Code Name
VENTILATOR, CONTINUOUS, FACILITY USE
Public Device Record Key
50d3073a-7a5f-4c71-83fb-2a69adf0bdd2
Public Version Date
March 04, 2021
Public Version Number
2
DI Record Publish Date
April 18, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 151 |
2 | A medical device with a moderate to high risk that requires special controls. | 3279 |