Home GUDID 00866271000039 ProCol Vascular Bioprosthesis
Primary DI 00866271000039
Brand ProCol Vascular Bioprosthesis
Company Hancock Jaffe Laboratories, Inc.
Model HJL016-40-N
Published 2014-08-14
Public version status Update
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 Code Name LXA Tissue Graft Of 6mm And Greater
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXA Tissue Graft Of 6mm And Greater Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00866271000039 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00866271000039 00866271000039 866271000039 0866271000039
GMDN Terms# Term, Definition table Term Definition Arteriovenous shunt A surgically-implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct ateriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 40 Centimeter Lumen/Inner Diameter 6 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 5 Degrees Celsius 25 Degrees Celsius
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 189530538 Device count 1 Serial number true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00866271000008 ProCol Vascular Bioprosthesis HJL016-10-N 2014-08-14 00866271000015 ProCol Vascular Bioprosthesis HJL016-25-N 2014-08-14 00866271000022 ProCol Vascular Bioprosthesis HJL016-30-N 2014-08-14
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00316837000367 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2019-07-29 00840663108657 ProCol Biologic Vascular Graft Lemaitre Vascular, Inc. LXA 2016-03-22 00840663108664 ProCol Biologic Vascular Graft Lemaitre Vascular, Inc. LXA 2016-03-22 00840663108671 ProCol Biologic Vascular Graft Lemaitre Vascular, Inc. LXA 2016-03-22 00840663108688 ProCol Biologic Vascular Graft Lemaitre Vascular, Inc. LXA 2016-03-22 00316837000343 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-30 00316837000190 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000206 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000213 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000220 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000237 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000244 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000251 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000268 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000275 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000282 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000299 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000305 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000312 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000329 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000336 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00316837000350 Artegraft Vascular Graft Lemaitre Vascular, Inc. LXA 2014-08-29 00866271000008 ProCol Vascular Bioprosthesis Hancock Jaffe Laboratories, Inc. LXA 2014-08-14 00866271000015 ProCol Vascular Bioprosthesis Hancock Jaffe Laboratories, Inc. LXA 2014-08-14 00866271000022 ProCol Vascular Bioprosthesis Hancock Jaffe Laboratories, Inc. LXA 2014-08-14