Crit-Line Cuvette

GUDID 10803622123136

LIVANOVA USA, INC.

Arteriovenous/external shunt connector Arteriovenous/external shunt connector

• Primary Device ID: 10803622123136
• NIH Device Record Key: 6c44faab-25da-4e72-a382-4bca372e5d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crit-Line Cuvette
• Version Model Number: Crit-Line Cuvette
• 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	00803622123139 [Primary]
GS1	10803622123136 [Package]; Contains: 00803622123139; Package: CASE [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991986

FDA Product Code

• CAC: APPARATUS, AUTOTRANSFUSION

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: 2015-05-01

Devices Manufactured by LIVANOVA USA, INC.

• 00803622156618 - Perfusion Pack: 2024-05-14
• 00803622156717 - Perfusion Pack: 2024-05-13
• 00803622156724 - Perfusion Pack: 2024-05-13
• 00803622156748 - Perfusion Pack: 2024-05-13
• 10803622156677 - Cardioplegia Pack: 2024-05-09
• 10803622156691 - Cardioplegia Pack: 2024-05-09
• 00803622156700 - Perfusion Pack: 2024-05-09
• 00803622156298 - Perfusion Pack: 2024-05-01