Venous cardiopulmonary bypass cannula

GUDID 10803622104043

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

• Primary Device ID: 10803622104043
• NIH Device Record Key: 18950472-d9b7-495f-bf2e-a00a547241d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venous cardiopulmonary bypass cannula
• Version Model Number: LR-xxxxx
• Company DUNS: 080914995
• Company Name: LIVANOVA USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00803622104046 [Primary]
GS1	10803622104043 [Package]; Contains: 00803622104046; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943934

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-15
• Device Publish Date: 2015-07-10

On-Brand Devices [Venous cardiopulmonary bypass cannula]

• 10803622128278: RT-xxxxx
• 00803622128264: RT-xxxxx
• 10803622128247: RT-xxxxx
• 10803622128230: RT-xxxxx
• 10803622128223: RD-xxxxx
• 10803622106825: RV-xxxxx
• 10803622106818: RV-xxxxx
• 10803622106801: RV-xxxxx
• 10803622106795: RV-xxxxx
• 10803622106788: RV-xxxxx
• 10803622106771: RV-xxxxx
• 10803622106764: RV-xxxxx
• 10803622106757: RV-xxxxx
• 10803622105798: RV-xxxxx
• 10803622105781: RV-xxxxx
• 10803622105774: RV-xxxxx
• 10803622105767: RV-xxxxx
• 10803622105750: RV-xxxxx
• 10803622105743: RV-xxxxx
• 10803622105736: RV-xxxxx
• 10803622105729: RV-xxxxx
• 10803622105712: RV-xxxxx
• 10803622105705: RV-xxxxx
• 10803622105699: RV-xxxxx
• 10803622105682: RV-xxxxx
• 10803622105675: RV-xxxxx
• 10803622105668: RV-xxxxx
• 10803622105651: RV-xxxxx
• 10803622105644: RV-xxxxx
• 10803622105637: RV-xxxxx
• 10803622105620: RV-xxxxx
• 10803622105613: RV-xxxxx
• 10803622105606: RV-xxxxx
• 10803622105590: RV-xxxxx
• 10803622105583: RV-xxxxx
• 10803622105576: RV-xxxxx
• 10803622105569: RV-xxxxx
• 10803622105552: RV-xxxxx
• 10803622105545: RV-xxxxx
• 10803622105538: RV-xxxxx
• 10803622105521: RV-xxxxx
• 10803622105514: RT-xxxxx
• 10803622105507: RT-xxxxx
• 10803622105491: RT-xxxxx
• 10803622105484: RT-xxxxx
• 10803622105477: RD-xxxxx
• 10803622105460: RD-xxxxx
• 10803622105453: RD-xxxxx
• 10803622105446: RD-xxxxx
• 10803622105439: RD-xxxxx