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 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 ID: 07290016069013
• NIH Device Record Key: e74d214c-7714-4d16-a323-613d89359824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioGard Emboli Protection Cannula
• Version Model Number: CGT2422
• Catalog Number: CGT2422
• Company DUNS: 533658675
• Company Name: CARDIOGARD MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter
• Circumference: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016069013 [Primary]
GS1	17290016069010 [Package]; Package: Shelf box [10 Units]; In Commercial Distribution
GS1	27290016069017 [Package]; Contains: 17290016069010; Package: Shipping box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182302

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-09
• Device Publish Date: 2022-06-01