Model: VT160-C2
DI: 18051160300768
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
368886c3-73d3-4385-af46-882b041fb669
Distribution Status:
In Commercial Distribution
DUNS Number:
436188505
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:
Yes
Identifiers
Device ID:
18051160300768
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17643
Name: Extracorporeal membrane oxygenator
Definition:
A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.
FDA Product Codes
DTZ
Oxygenator, Cardiopulmonary Bypass
Premarket Submissions
Submission Number:
K212341
Supplement Number:
000