Smart Connector

GUDID 10803622124966

LIVANOVA USA, INC.

Arteriovenous/external shunt connector

• Primary Device ID: 10803622124966
• NIH Device Record Key: 1cbe4876-f1fc-4861-b89a-cefad4b1b1c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Connector
• Version Model Number: Smart Connector
• 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	00803622124969 [Primary]
GS1	10803622124966 [Package]; Contains: 00803622124969; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981613

FDA Product Code

• DTL: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, 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: 2015-05-19

On-Brand Devices [Smart Connector]

• 10803622124980: Smart Connector
• 10803622124973: Smart Connector
• 10803622124966: Smart Connector
• 10803622124959: Smart Connector