AccessGUDID - DEVICE: Cannula Graft™ (05037881009537)

GUDID

Device Identifier (DI) Information

Brand Name: Cannula Graft™
Version or Model: CGS2008S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CGS2008S
Company Name: VASCUTEK LTD

Primary DI Number: 05037881009537
Issuing Agency: GS1
Commercial Distribution End Date:
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Cardiopulmonary bypass cannula, arterial	A sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Cardiopulmonary bypass cannula, arterial

A sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081560	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

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Storage and Handling
Special Storage Condition, Specify: Store in a clean dry area.
Handling Environment Temperature: between 0 and 35 Degrees Celsius

Clinically Relevant Size

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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: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015