Vein Irrigation

GUDID 10803622133098

LIVANOVA USA, INC.

Vascular dilator, reusable

• Primary Device ID: 10803622133098
• NIH Device Record Key: e2b4e9e8-377e-4474-92ac-9d6ae8a35873
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vein Irrigation
• Version Model Number: BIC
• 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	00803622133091 [Primary]
GS1	10803622133098 [Package]; Contains: 00803622133091; Package: CASE [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900753

FDA Product Code

• DWP: DILATOR, VESSEL, SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-15
• Device Publish Date: 2016-08-01

On-Brand Devices [Vein Irrigation]

• 10803622133104: VIC
• 10803622133098: BIC