FDA.reportPublic FDA data

HeRO®

Primary DI
00884450329559
Brand
HeRO®
Company
Merit Medical Systems, Inc.
Model
00884450329559
Catalog number
HERO1001VOC
Published
2018-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450329556PackageGS11In Commercial Distribution
20884450329553PackageGS110In Commercial Distribution
00884450329559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445032955610884450329556
2088445032955320884450329553
00884450329559008844503295598844503295590884450329559

GMDN Terms#

Term, Definition table
TermDefinition
Arteriovenous shuntAn 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
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24
00884450277652Safety Paracentesis Procedure TrayInitial ReleaseSPPT-8F-10S2026-09-22
00884450416723SureCrossDSC18652026-09-22
00884450422755SureCrossDSC14902026-09-22
00884450423110SureCrossDSC14652026-09-22
00884450427170SureCrossDSC141352026-09-22
00884450428016Merit Medical®Initial ReleaseK10-03360H2026-09-22
00884450435526Merit Medical®Initial ReleaseK09-11159A2026-09-22
00884450445419Merit Medical®Initial ReleaseK09-01589X2026-09-22
00884450473313Merit Medical®Initial ReleaseK09-14357A2026-09-22
00884450852279Merit Medical®Initial ReleasePC8112026-09-22
00884450852286Merit Medical®Initial ReleasePC8122026-09-22
10884450489809Prelude SNAP™APLSX-25112026-09-22
10884450489816Prelude SNAP™APLSS-10062026-09-22
10884450489823Prelude SNAP™APLSS-10072026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05037881184883Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184890Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184906Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184913Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184920Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184937Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
00733132600038GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600052GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600076GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600090GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132605354GORE ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607068GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607129GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607143GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607150GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607174GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607181GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607211GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607228GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607235GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607242GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607259GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607266GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607273GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13