RAP Femoral Venous Cannula

GUDID 10803622147149

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral

• Primary Device ID: 10803622147149
• NIH Device Record Key: 9c363a6c-6376-489a-9379-d542ca84510c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAP Femoral Venous Cannula
• Version Model Number: 200-150J
• Company DUNS: 080914995
• Company Name: LIVANOVA USA, INC.
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00803622147142 [Primary]
GS1	10803622147149 [Package]; Contains: 00803622147142; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052081

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: 2020-09-29
• Device Publish Date: 2020-09-21

On-Brand Devices [RAP Femoral Venous Cannula]

• 10803622128094: 200-150
• 10803622128087: 200-100
• 10803622125802: 200-150
• 10803622125796: 200-100
• 10803622147149: 200-150J
• 10803622147217: 200-100J