Device
Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
Manufacturer
EUROSETS SRL
EUROSETS SRL
Model: Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
Catalog: US5232
DI: 08054117372446
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
37adb444-aee7-46d7-8f08-7ebd0a3cdd7b
Distribution Status:
In Commercial Distribution
DUNS Number:
439962374
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
08054117372446
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
18054117372443
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
08054117372446
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
28054117372440
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
2
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
18054117372443
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
DTZ
Oxygenator, Cardiopulmonary Bypass
DTN
Reservoir, Blood, Cardiopulmonary Bypass
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
DTR
Heat-Exchanger, Cardiopulmonary Bypass
Premarket Submissions
Submission Number:
K242503
Supplement Number:
000