FDA.report

GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet

Primary DI
10801741012164
Brand
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet
Company
Bard Access Systems, Inc.
Model
5393150
Catalog number
5393150
Device description
GLIDEPATH HEMODIALYSIS CATH, ST, DL, 14.5 FR. 15cm
Published
2015-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MSDCatheter, hemodialysis, implanted

Product Code Classifications

CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741012164PackageGS15In Commercial Distribution
00801741012167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101216410801741012164
00801741012167008017410121678017410121670801741012167

GMDN Terms

TermDefinition
Double-lumen haemodialysis catheter, implantableA sterile, 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. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge14.5French
Length15Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags

DUNS number
044611812
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

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10801741231275CentroVena One1K0R72161K0R72162026-01-23
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10801741231329CentroVena One1K0R73301K0R73302026-01-23
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