Home GUDID 00866271000022 ProCol Vascular Bioprosthesis
Primary DI 00866271000022
Brand ProCol Vascular Bioprosthesis
Company Hancock Jaffe Laboratories, Inc.
Model HJL016-30-N
Published 2014-08-14
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 00866271000022 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 00866271000022 00866271000022 866271000022 0866271000022
GMDN Terms# Term, Definition table Term Definition Arteriovenous shunt An 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 arteriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0 Lumen/Inner Diameter 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 189530538 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00866271000039 ProCol Vascular Bioprosthesis HJL016-40-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 00866271000039 ProCol Vascular Bioprosthesis Hancock Jaffe Laboratories, Inc. LXA 2014-08-14