Model: DL31F-VS
DI: 18051160301710
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:
935523c9-0a5e-41d1-ad2a-8564a95e40aa
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:
18051160301710
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34905
Name: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Definition:
A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as a venous cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.
FDA Product Codes
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Premarket Submissions
Submission Number:
K221353
Supplement Number:
000