FDA.reportPublic FDA data

ProGuide™

Primary DI
10884450826864
Brand
ProGuide™
Company
Merit Medical Systems, Inc.
Model
G
Catalog number
63132
Published
2024-12-07
Public version status
New
Distribution status
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
CodeName
MSDCatheter, hemodialysis, implanted

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450826864PackageGS15In Commercial Distribution
00884450826867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445082686410884450826864
00884450826867008844508268678844508268670884450826867

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
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
false
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
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
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450458426DuraMax®Merit Medical Systems, Inc.MSD2026-03-24
00884450458303DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458310DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458327DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458358DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
10884450458409DuraMax®Merit Medical Systems, Inc.MSD2026-03-20
00884450458433DuraMaxMerit Medical Systems, Inc.MSD2026-03-20
10884450458218DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458362DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458386DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458416DuraMax®Merit Medical Systems, Inc.MSD2026-03-19
10884450458232DuraMax®Merit Medical Systems, Inc.MSD2026-03-11
10884450793913BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-02-28
10884450795078DuraFlow™2Merit Medical Systems, Inc.MSD2026-02-26
10884450826888ProGuide™Merit Medical Systems, Inc.MSD2026-01-13
10884450793791BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-01-03
10884450794804DuraMax®Merit Medical Systems, Inc.MSD2026-01-03
10884450795115DuraFlow™2Merit Medical Systems, Inc.MSD2026-01-03
50884908185145MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
50884908185152MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
20884521811116RitusMozarc Medical US LLCMSD2025-11-27
10884450794828DuraMax®Merit Medical Systems, Inc.MSD2025-09-13
10884450795030DuraFlow™2Merit Medical Systems, Inc.MSD2025-09-06
10884450793777BioFlo DuraMax®Merit Medical Systems, Inc.MSD2025-09-04
10884450795122DuraFlow™2Merit Medical Systems, Inc.MSD2025-07-26
10884450793227BioFlo DuraMax®Merit Medical Systems, Inc.MSD2025-07-23
10884450820787CentrosFLO®Merit Medical Systems, Inc.MSD2025-07-23
10884450827236ProGuide™Merit Medical Systems, Inc.MSD2025-07-16
10884450820794CentrosFLO®Merit Medical Systems, Inc.MSD2025-07-11
50884908130503Hemo-Flow®Medical Components, Inc.MSD2025-06-26