Venous Line Clamp

GUDID 04033817900061

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817900061
• NIH Device Record Key: c99738c6-c809-426a-9e2d-f082f6fc11f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venous Line Clamp
• Version Model Number: Plastic Inserts 1/2" x 1/16"
• Company DUNS: 343225272
• Company Name: LivaNova Deutschland GmbH
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04033817900061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071318

FDA Product Code

• DTQ: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-05-07
• Device Publish Date: 2015-10-14

On-Brand Devices [Venous Line Clamp]

• 04033817900498: with Remote Control
• 04033817900177: Metal Inserts 5/8" x 3/32"
• 04033817900160: Metal Inserts 1/2" x 3/32"
• 04033817900153: Metal Inserts 1/2" x 1/16"
• 04033817900146: Metal Inserts 3/8" x 3/32"
• 04033817900139: Metal Inserts 3/8" x 1/16"
• 04033817900122: Metal Inserts 1/4" x 3/32"
• 04033817900115: Metal Inserts 1/4" x 1/16"
• 04033817900108: Plastic Inserts 3/16" x 1/16"
• 04033817900092: Plastic Inserts 1/8" x 1/16"
• 04033817900085: Plastic Inserts 5/8" x 3/32"
• 04033817900078: Plastic Inserts 1/2" x 3/32"
• 04033817900061: Plastic Inserts 1/2" x 1/16"
• 04033817900054: Plastic Inserts 3/8" x 3/32"
• 04033817900047: Plastic Inserts 3/8" x 1/16"
• 04033817900030: Plastic Inserts 1/4" x 3/32"
• 04033817900023: Plastic Inserts 1/4" x 1/16"