FDA.reportPublic FDA data

HeRO®

Primary DI
10884450415273
Brand
HeRO®
Company
Merit Medical Systems, Inc.
Model
00884450415276
Catalog number
HERO1002/D
Published
2021-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203724000HeRO Graft, HeRO AdapterMerit Medical Systems, Inc.2021-05-25DSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450415273PackageGS11In Commercial Distribution
00884450415276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445041527310884450415273
00884450415276008844504152768844504152760884450415276

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06
00884450436745Merit Medical®Initial ReleaseK09-13832A2026-06-06
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00733132607280GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607297GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607303GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611508GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611539GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611546GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13