CardioGard Emboli Protection Cannula CGT2422

GUDID 07290016069013

24 Fr. (8.00 mm) Cardiopulmonary bypass cannula, arterial, for use in aorta, with suction port in tip to allow emboli removal during cardiopulmonary bypass.

CARDIOGARD MEDICAL LTD

Cardiopulmonary bypass cannula, arterial
Primary Device ID07290016069013
NIH Device Record Keye74d214c-7714-4d16-a323-613d89359824
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioGard Emboli Protection Cannula
Version Model NumberCGT2422
Catalog NumberCGT2422
Company DUNS533658675
Company NameCARDIOGARD MEDICAL 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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016069013 [Primary]
GS117290016069010 [Package]
Package: Shelf box [10 Units]
In Commercial Distribution
GS127290016069017 [Package]
Contains: 17290016069010
Package: Shipping box [6 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-09
Device Publish Date2022-06-01

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