Thin-Flex Single Stage Malleable Venous Drainage Cannula

Basic Information

• Brand Name: Thin-Flex Single Stage Malleable Venous Drainage Cannula
• Primary DI: 00690103153255
• Version / Model: TFM036L
• Catalog Number: TFM036L
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: b6566234-a82b-4908-9306-ae173ffe048f
• Distribution End Date: 2017-12-31

Device Description

Single Stage Venous Return Cannula

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34905	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous	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. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103153255	GS1
Package	50690103153250	GS1	Shipper	10	Not in Commercial Distribution	2017-12-31

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120072	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			36 Fr. (12.0 mm) x 40 cm (16")