Surfacer Inside-Out Access Catheter System 600200/A

GUDID 00860003451601

BLUEGRASS VASCULAR TECHNOLOGIES, INC.

Central venous catheter inside-out introduction set

• Primary Device ID: 00860003451601
• NIH Device Record Key: a958442c-46f9-4ba8-986f-5db67fb84ce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surfacer Inside-Out Access Catheter System
• Version Model Number: 600200/A
• Catalog Number: 600200/A
• Company DUNS: 080441650
• Company Name: BLUEGRASS VASCULAR TECHNOLOGIES, 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003451601 [Primary]
GS1	10860003451608 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190038

FDA Product Code

• QJH: Reverse Central Venous Recanalization System

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: 2020-03-06
• Device Publish Date: 2020-02-27