Arterial cardiopulmonary bypass cannula

GUDID 10803622104432

LIVANOVA USA, INC.

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: 10803622104432
• NIH Device Record Key: 384acd63-70f2-4633-907f-0cd180ea2d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arterial cardiopulmonary bypass cannula
• Version Model Number: NA-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	00803622104435 [Primary]
GS1	10803622104432 [Package]; Contains: 00803622104435; 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: 2015-07-17

On-Brand Devices [Arterial cardiopulmonary bypass cannula]

• 10803622106740: RA-xxxxx
• 10803622106733: NA-xxxxx
• 10803622106726: NA-xxxxx
• 10803622106719: NA-xxxxx
• 10803622106702: NA-xxxxx
• 10803622106696: NA-xxxxx
• 10803622106689: NA-xxxxx
• 10803622106672: NA-xxxxx
• 10803622106665: NA-xxxxx
• 10803622106658: NA-xxxxx
• 10803622105170: RA-xxxxx
• 10803622105163: RA-xxxxx
• 10803622105156: RA-xxxxx
• 10803622105149: RA-xxxxx
• 10803622105132: RA-xxxxx
• 10803622105125: RA-xxxxx
• 10803622105118: RA-xxxxx
• 10803622105101: RA-xxxxx
• 10803622105095: RA-xxxxx
• 10803622105088: RA-xxxxx
• 10803622105071: RA-xxxxx
• 10803622105064: RA-xxxxx
• 10803622105057: RA-xxxxx
• 10803622105040: RA-xxxxx
• 10803622105033: RA-xxxxx
• 10803622105026: RA-xxxxx
• 10803622105019: RA-xxxxx
• 10803622105002: RA-xxxxx
• 10803622104999: RA-xxxxx
• 10803622104982: RA-xxxxx
• 10803622104975: RA-xxxxx
• 10803622104562: NA-xxxxx
• 10803622104555: NA-xxxxx
• 10803622104548: NA-xxxxx
• 10803622104531: NA-xxxxx
• 10803622104524: NA-xxxxx
• 10803622104517: NA-xxxxx
• 10803622104500: NA-xxxxx
• 10803622104494: NA-xxxxx
• 10803622104487: NA-xxxxx
• 10803622104470: NA-xxxxx
• 10803622104463: NA-xxxxx
• 10803622104456: NA-xxxxx
• 10803622104449: NA-xxxxx
• 10803622104432: NA-xxxxx
• 10803622104425: NA-xxxxx
• 10803622104418: NA-xxxxx
• 10803622104401: NA-xxxxx
• 10803622104395: NA-xxxxx
• 10803622104388: NA-xxxxx