FDA.reportPublic FDA data

BioFlo DuraMax®

Primary DI
00884450793336
Brand
BioFlo DuraMax®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
H965103028230
Published
2024-08-13
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
CodeName
MSDCatheter, hemodialysis, implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131260000NMI DIALYSIS CATHETERNavilyst Medical, Inc.2014-02-14MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450793336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450793336008844507933368844507933360884450793336

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableAn implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) 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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450030301Merit Medical®Initial ReleaseK08-02374A2026-09-18
00884450101315Merit Medical®Initial ReleaseK12T-11002F2026-09-18
00884450121368Merit Medical®Initial ReleaseK04-00791B2026-09-19
00884450265260Merit Medical®Initial ReleaseK09T-10440D2026-09-18
00884450276808Merit Medical®Initial ReleaseK12T-084642026-09-18
00884450277164Merit Medical®Initial ReleaseK09T-09666F2026-09-18
00884450295854Merit Medical®Initial ReleaseK12T-094032026-09-18
00884450306628Merit Medical®Initial ReleaseK12T-02866A2026-09-18
00884450306635Merit Medical®Initial ReleaseK09T-10276A2026-09-18
00884450306642Merit Medical®Initial ReleaseK12T-03836A2026-09-18
00884450320150Merit Medical®Initial ReleaseK10T-052102026-09-18
00884450320426Merit Medical®Initial ReleaseK10T-053242026-09-18
00884450336922Merit Medical®Initial ReleaseK09T-115672026-09-18
00884450339589Merit Medical®Initial ReleaseK12T-031482026-09-18
00884450340011Merit Medical®Initial ReleaseK12T-035362026-09-18
00884450352069Merit Medical®Initial ReleaseK12T-078402026-09-18
00884450428443Merit Medical®Initial ReleaseK10-01694R2026-09-18
00884450428955Merit Medical®Initial ReleaseK09-14183A2026-09-18
00884450431740Merit Medical®Initial ReleaseK09-10388B2026-09-18
00884450432068Merit Medical®Initial ReleaseK09-07593C2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450458204DuraMax®Merit Medical Systems, Inc.MSD2026-08-17
00884908189674MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2026-08-08
00884908189681MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2026-08-08
00884908189698MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2026-08-08
00884908189704MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2026-08-08
00884908189711MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2026-08-08
00884908189728MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2026-08-08
00884450468951DuraMax®Merit Medical Systems, Inc.MSD2026-07-31
10801902193527ARROWTELEFLEX INCORPORATEDMSD2026-07-30
10801902193619ARROWTELEFLEX INCORPORATEDMSD2026-07-30
10801902193626ARROWTELEFLEX INCORPORATEDMSD2026-07-30
10801902193633ARROWTELEFLEX INCORPORATEDMSD2026-07-30
10801902193688ARROWTELEFLEX INCORPORATEDMSD2026-07-30
10801902194463ARROWTELEFLEX INCORPORATEDMSD2026-07-30
00884450827284ProGuide™Merit Medical Systems, Inc.MSD2026-07-29
10801902193640ARROWTELEFLEX INCORPORATEDMSD2026-07-27
10801902193657ARROWTELEFLEX INCORPORATEDMSD2026-07-27
10801902193664ARROWTELEFLEX INCORPORATEDMSD2026-07-27
10801902193671ARROWTELEFLEX INCORPORATEDMSD2026-07-27
00884450793817BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-07-25
20801902193548ARROWTELEFLEX INCORPORATEDMSD2026-07-23
20801902193593ARROWTELEFLEX INCORPORATEDMSD2026-07-23
30801902193538ARROWTELEFLEX INCORPORATEDMSD2026-07-22
00884450468913DuraMax®Merit Medical Systems, Inc.MSD2026-07-08
00884450820759CentrosFLO®Merit Medical Systems, Inc.MSD2026-06-25
00884450467572DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469033BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469132BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450794760DuraMax®Merit Medical Systems, Inc.MSD2026-06-02
00884908185157MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27