Surfacer Inside-Out Access Catheter System

Primary DI
00860003451601
Brand
Surfacer Inside-Out Access Catheter System
Company
BLUEGRASS VASCULAR TECHNOLOGIES, INC.
Model
600200/A
Catalog number
600200/A
Published
2020-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QJHReverse Central Venous Recanalization System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJHReverse Central Venous Recanalization SystemCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190038000Surfacer Inside-Out Access Catheter SystemBluegrass Vascular Technologies, Inc.2020-02-10QJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860003451608PackageGS11In Commercial Distribution
00860003451601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000345160810860003451608
00860003451601008600034516018600034516010860003451601

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheter inside-out introduction setA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080441650
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450419809Surfacer®Merit Medical Systems, Inc.QJH2026-02-18
00884450762158Surfacer®Merit Medical Systems, Inc.QJH2024-03-02