Surfacer Inside-Out Access Catheter System

Basic Information

• Brand Name: Surfacer Inside-Out Access Catheter System
• Primary DI: 00860003451601
• Version / Model: 600200/A
• Catalog Number: 600200/A
• Company Name: BLUEGRASS VASCULAR TECHNOLOGIES, INC.
• Labeler DUNS: 080441650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-27
• Public Version: 1
• Public Version Date: 2020-03-06
• Public Version Status: New
• Public Device Record Key: a958442c-46f9-4ba8-986f-5db67fb84ce9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJH	Reverse Central Venous Recanalization System	Cardiovascular	870.1342	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62045	Central venous catheter inside-out introduction set	A collection of sterile, invasive devices intended to enable introduction of a central venous catheter (CVC) into an occluded vein (e.g., subclavian) by creating a puncture site from the inside of the vein under fluoroscopic guidance. It typically includes: an introducer sheath, for initial vascular access via a secondary vein (e.g., femoral); a semi-rigid, noncoring, endovascular guide sheath assembly with a distal side-hole, intended to navigate into, and be stabilized by, the vascular occlusion; a percutaneous needle-wire, intended to puncture the vein/tissue to exit at the skin surface; and a sheath for introduction of a CVC; the catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003451601	GS1
Package	10860003451608	GS1		1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
DEN190038	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 50 Degrees Celsius