FDA.reportPublic FDA data

GlidePath

Primary DI
10801741176354
Brand
GlidePath
Company
Bard Peripheral Vascular, Inc.
Model
5393150R
Catalog number
5393150R
Device description
GlidePath Retro Long-Term Hemodialysis Catheter, 15 cm
Published
2021-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10801741176354PackageGS15In Commercial Distribution
00801741176357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174117635410801741176354
00801741176357008017411763578017411763570801741176357

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
Catheter Gauge14.5French
Length15Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741000331UltraClip® II Breast Tissue Marker8610178610172015-09-25
00801741032004SenoMark® Ultra Breast Tissue MarkerSMEC7CSMEC7C2015-10-02
00801741032011SenoMark® Ultra Breast Tissue MarkerSMEC7RSMEC7R2015-10-02
00801741032028SenoMark® Ultra Breast Tissue MarkerSMEC10CSMEC10C2015-10-01
00801741032035SenoMark® Ultra Breast Tissue MarkerSMEC10RSMEC10R2015-10-01
00801741032042SenoMark® Ultra Breast Tissue MarkerSMEC12CSMEC12C2015-10-01
00801741032059SenoMark® Ultra Breast Tissue MarkerSMEC12RSMEC12R2015-10-02
00801741032066SenoMark® Ultra Breast Tissue MarkerSMMA11CSMMA11C2015-10-01
00801741032073SenoMark® Ultra Breast Tissue MarkerSMMA11RSMMA11R2015-10-01
00801741032080SenoMark® Ultra Breast Tissue MarkerSMAT9CSMAT9C2015-10-02
00801741032097SenoMark® Ultra Breast Tissue MarkerSMAT9RSMAT9R2015-10-02
00801741032103SenoMark® Ultra Breast Tissue MarkerSMAT12CSMAT12C2015-10-01
00801741032110SenoMark® Ultra Breast Tissue MarkerSMAT12RSMAT12R2015-10-01
00801741032127SenoMark® Ultra Breast Tissue MarkerSMEV9CSMEV9C2015-10-02
00801741032134SenoMark® Ultra Breast Tissue MarkerSMEV9RSMEV9R2015-10-02
00801741032219UltraClip® Dual Trigger Breast Tissue Marker862017D862017D2015-09-25
00801741032226UltraClip® Dual Trigger Breast Tissue Marker862017DL862017DL2015-09-25
00801741032233UltraClip® Dual Trigger Breast Tissue Marker863017D863017D2015-09-25
00801741032240UltraClip® Dual Trigger Breast Tissue Marker863017DL863017DL2015-09-25
00801741032257UltraClip® Dual Trigger Breast Tissue Marker864017D864017D2015-09-25

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