FDA.reportPublic FDA data

BioFlo DuraMax®

Primary DI
00884450794012
Brand
BioFlo DuraMax®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
H965103038240
Published
2024-08-01
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
00884450794012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450794012008844507940128844507940120884450794012

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
00884450031131Merit Medical®Initial ReleaseK08-02653A2026-05-28
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28
00884450392867SCOUT MD™Initial ReleaseMDS05B-012026-05-28
00884450392874SCOUT MD™Initial ReleaseMDS05C-012026-05-28
00884450392881SCOUT MD™Initial ReleaseMDS05M-012026-05-28
00884450392935SCOUT MD™Initial ReleaseMDS75A-012026-05-28
00884450392942SCOUT MD™Initial ReleaseMDS75B-012026-05-28
00884450392959SCOUT MD™Initial ReleaseMDS75C-012026-05-28
00884450392966SCOUT MD™Initial ReleaseMDS75M-012026-05-28
00884450428313Merit Medical®Initial ReleaseK09-09671B2026-05-28
00884450430057Merit Medical®Initial ReleaseK12-01244B2026-05-28
00884450487532Merit Medical®Initial ReleaseK09T-136472026-05-28
00884450487549Merit Medical®Initial ReleaseK12T-11710A2026-05-28
00884450487679Merit Medical®Initial ReleaseK10T-06195A2026-05-28
00884450766958Performa®B1623-F820M2026-05-28
10884450415358Prelude®JPSI-4F-23MT2026-05-28
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902096606ARROWTELEFLEX INCORPORATEDMSD2018-06-26
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10801902096668ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801741074490ClampsBard Access Systems, Inc.MSD2016-09-16
10801902126693ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126709ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126716ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126723ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126730ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126747ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126754ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126761ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126778ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126785ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126792ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126808ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127157ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127164ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127171ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127188ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127195ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127201ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127218ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127225ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127232ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127249ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127256ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127263ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127270ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127287ARROWTELEFLEX INCORPORATEDMSD2016-09-16