AccessGUDID - DEVICE: Cannula Graft™ (05037881009537)

GUDID

Device Identifier (DI) Information

Brand Name: Cannula Graft™
Version or Model: CGS2008S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CGS2008S
Company Name: VASCUTEK LTD

Primary DI Number: 05037881009537
Issuing Agency: GS1
Commercial Distribution End Date: August 13, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 229053087 *Terms of Use

Device Description: Cannula Graft PVC Cannula with Gelatin Sealed ePTFE Vascular Prosthesis

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":	Yes
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?
34893	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return	A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial 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
Special Storage Condition, Specify: Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 8 Millimeter
Device Size Text, specify: Graft Length 20cm
Length: 50 Centimeter

Device Record Status

Public Device Record Key: 53deba1a-0629-472d-aafd-178f8ffda085
Public Version Date: June 19, 2024
Public Version Number: 7
DI Record Publish Date: October 24, 2015