Vascular Dilator Kit

GUDID 00803622146947

LIVANOVA USA, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00803622146947
• NIH Device Record Key: 320ec27b-8c5b-48e7-b071-a36b51ffc540
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vascular Dilator Kit
• Version Model Number: 200-120
• 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	00803622146947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070749

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-27
• Device Publish Date: 2020-08-19

On-Brand Devices [Vascular Dilator Kit]

• 00803622112522: 200-120
• 00803622146947: 200-120