Duns Number:080728314
Device Description: Trilogy Evo Ventilator with Oxygen Blending Module, India
Catalog Number
IA2100X15B
Brand Name
Trilogy Evo
Version/Model Number
Trilogy Evo, O2, India
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 05, 2021
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"
-
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
b2abee6a-dbc9-4439-b6b9-f8494aa8cda3
Public Version Date
March 05, 2021
Public Version Number
2
DI Record Publish Date
October 07, 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 |