Pressure monitoring tubing

GUDID 10803622106603

LIVANOVA USA, INC.

Cardiopulmonary bypass system tubing connector

• Primary Device ID: 10803622106603
• NIH Device Record Key: 067bbe51-b0ca-4ae0-9f26-c2b19d5e0fbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pressure monitoring tubing
• Version Model Number: AX-xxxxx
• 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	00803622106606 [Primary]
GS1	10803622106603 [Package]; Contains: 00803622106606; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993818

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: 2015-07-16

On-Brand Devices [Pressure monitoring tubing]

• 10803622106603: AX-xxxxx
• 10803622103565: AX-xxxxx
• 10803622103558: AX-xxxxx
• 10803622103541: AX-xxxxx
• 10803622103534: AX-xxxxx
• 10803622103527: AX-xxxxx
• 10803622103510: AX-xxxxx