Device
enableCV ThinFlex Single Stage Venous Drainage Cannula - TF016L
Manufacturer
ENABLECV INC.
ENABLECV INC.
Model: TF016L
DI: 00840479401973
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
enableCV ThinFlex Single Stage Venous Drainage Cannula - TF016L
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0b6488d9-9cac-4da6-b836-97d8053ce6a0
Distribution Status:
In Commercial Distribution
DUNS Number:
119247843
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:
00840479401980
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00840479401973
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00840479401973
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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:
K120072
Supplement Number:
000
Device Sizes
Device Size - Size Text:
16 Fr. (5.3 mm) x 28 cm (11")
Device Size - Size Type:
Device Size Text, specify
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Store sterile packaged device in a cool, dry place.