AccessGUDID - DEVICE: Surfacer Inside-Out Access Catheter System (00860003451601)

GUDID

Device Identifier (DI) Information

Brand Name: Surfacer Inside-Out Access Catheter System
Version or Model: 600200/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 600200/A
Company Name: BLUEGRASS VASCULAR TECHNOLOGIES, INC.

Primary DI Number: 00860003451601
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080441650 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJH	Reverse Central Venous Recanalization System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190038	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a958442c-46f9-4ba8-986f-5db67fb84ce9
Public Version Date: March 06, 2020
Public Version Number: 1
DI Record Publish Date: February 27, 2020