Cannula Graft™ CGS2008S

GUDID 05037881009537

Cannula Graft PVC Cannula with Gelatin Sealed ePTFE Vascular Prosthesis

VASCUTEK LTD

Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial
Primary Device ID05037881009537
NIH Device Record Key53deba1a-0629-472d-aafd-178f8ffda085
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannula Graft™
Version Model NumberCGS2008S
Catalog NumberCGS2008S
Company DUNS229053087
Company NameVASCUTEK LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Length50 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.

Device Identifiers

Device Issuing AgencyDevice ID
GS105037881009537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-25
Device Publish Date2015-10-24

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