FDA.report

RELIANCE XK Long-Term Hemodialysis Catheter

Primary DI
10801741012102
Brand
RELIANCE XK Long-Term Hemodialysis Catheter
Company
Bard Access Systems, Inc.
Model
5327230
Catalog number
5327230
Device description
RELIANCE XK HEMODIALYSIS CATH, ST, DL, 16 FR. 23cm
Published
2015-05-27
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
10801741012102PackageGS15In Commercial Distribution
00801741012105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101210210801741012102
00801741012105008017410121058017410121050801741012105

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 Gauge16French
Length23Centimeter

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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10801741231350CentroVena One1MB0R73161MB0R73162026-01-23
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