Spike

GUDID 10803622129374

LIVANOVA USA, INC.

Arteriovenous/external shunt connector

• Primary Device ID: 10803622129374
• NIH Device Record Key: 40ed1eed-ac60-4af3-9321-7412e1c16573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spike
• Version Model Number: Spike
• 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	00803622129377 [Primary]
GS1	10803622129374 [Package]; Contains: 00803622129377; Package: CASE [20 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: 2015-11-30

Devices Manufactured by LIVANOVA USA, INC.

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• 00803622158049 - Perfusion Pack: 2024-11-13
• 10803622157520 - Perfusion Pack: 2024-11-05
• 00803622157981 - Perfusion Pack: 2024-11-05
• 10803622158008 - Perfusion Pack: 2024-11-05
• 00803622158018 - Perfusion Pack: 2024-11-05