Duns Number:080728314
Device Description: Trilogy Evo Ventilator system with oxygen blending module, Turkey
Catalog Number
TR2100X15B
Brand Name
Trilogy Evo, O2
Version/Model Number
TR2100X15B
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
K181166
Product Code
CBK
Product Code Name
Ventilator, continuous, facility use
Public Device Record Key
b665f8c8-d869-47e0-99e2-2841410b2fc3
Public Version Date
July 06, 2020
Public Version Number
1
DI Record Publish Date
June 26, 2020
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 |