FDA.report

Hickman Hemodialysis/Apheresis Catheter

Primary DI
10801741037549
Brand
Hickman Hemodialysis/Apheresis Catheter
Company
Bard Access Systems, Inc.
Model
0600692
Catalog number
0600692
Device description
Hickman Hemodialysis/Apheresis Catheter 13.5F Dual-Lumen Catheter 40cm Overall Length, 23cm Tip-to-Cuff Length Standard Kit (with Peel-Apart Introducer)
Published
2015-06-24
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
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741037549PackageGS112In Commercial Distribution
00801741037542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103754910801741037549
00801741037542008017410375428017410375420801741037542

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 Gauge13.5French
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
false
Sterilization required before use
false

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