AccessGUDID - DEVICE: Thin-Flex Dual Stage Venous Drainage Cannula (00690103041682)

GUDID

Device Identifier (DI) Information

Brand Name: Thin-Flex Dual Stage Venous Drainage Cannula
Version or Model: TF3646OA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TF3646OA
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103041682
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: THIN-FLEX DUAL STAGE VENOUS CANNULA

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34905	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120072	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 36/46 Fr. (12.0/15.3 mm) X 40 cm (16")

Device Record Status

Public Device Record Key: f0f5495c-deed-48a0-a706-6c761604a1c5
Public Version Date: June 19, 2024
Public Version Number: 7
DI Record Publish Date: August 31, 2016