AccessGUDID - DEVICE: Venous Cardiopolmunary Bypass Cannula (08033178018401)

GUDID

Device Identifier (DI) Information

Brand Name: Venous Cardiopolmunary Bypass Cannula
Version or Model: RV-40024
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SORIN GROUP ITALIA SRL

Primary DI Number: 08033178018401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 442126587 *Terms of Use

Device Description: No description.

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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c0eec04-f519-44b8-9c57-72f800c65beb
Public Version Date: March 19, 2026
Public Version Number: 2
DI Record Publish Date: December 19, 2025