FDA.report

Soft-Cell PC Dialysis Catheter Kit 12.5 F x 23 cm

Primary DI
20801741012406
Brand
Soft-Cell PC Dialysis Catheter Kit 12.5 F x 23 cm
Company
Bard Access Systems, Inc.
Model
5533230
Catalog number
5533230
Device description
SOFT-CELL DIALYSIS CATH, PC, DL, 12.5 FR. 23cm
Published
2017-05-29
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
LFJCATHETER, SUBCLAVIAN

Product Code Classifications

CodeDeviceSpecialtyClass
LFJCatheter, SubclavianGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741012409PackageGS15In Commercial Distribution
20801741012406PackageGS110In Commercial Distribution
00801741012402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101240910801741012409
2080174101240620801741012406
00801741012402008017410124028017410124020801741012402

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 Gauge12.5French
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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