FDA.reportPublic FDA data

Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 17 cm

Primary DI
10801741012362
Brand
Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 17 cm
Company
Bard Access Systems, Inc.
Model
5500100
Catalog number
5500100
Device description
SOFT-CELL DIALYSIS CATH, PC, DL, 12.5 FR. 17cm
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFJCATHETER, SUBCLAVIAN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFJCatheter, SubclavianGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741012362PackageGS15In Commercial Distribution
20801741012369PackageGS110In Commercial Distribution
00801741012365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101236210801741012362
2080174101236920801741012369
00801741012365008017410123658017410123650801741012365

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12.5French
Length17Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741036712Groshong771070077107002015-09-24
00801741036729Groshong771155077115502015-09-24
00801741037696Groshong772495077249502015-09-24
00801741037719Groshong774155077415502015-09-24
10801741239356PowerPICC Sherlock 3CGCK001067ACK001067A2026-03-11
10801741239363PowerPICC ProvenaCK001068ACK001068A2026-03-11
10801741239370PowerPICC ProvenaCK001069ACK001069A2026-03-11
10801741239271MiniLocCPA00072CPA000722026-02-26
10801741238830PowerPICC Provena SOLOCK001091CK0010912026-02-11
00801741038464Niagara Slim-Cath catheter543215054321502015-12-04
00801741038471Niagara Slim-Cath Catheter543220054322002015-11-20
00801741038488Niagara Slim-Cath catheter543224054322402015-12-04
00801741045141Niagara Slim-Cath catheter543412054341202015-11-20
00801741045158Niagara Slim-Cath catheter543415054341502015-11-06
10801741231275CentroVena One1K0R72161K0R72162026-01-23
10801741231282CentroVena One1K0R72201K0R72202026-01-23
10801741231305CentroVena One1K0R73161K0R73162026-01-23
10801741231312CentroVena One1K0R73201K0R73202026-01-23
10801741231329CentroVena One1K0R73301K0R73302026-01-23
10801741231336CentroVena One1MB0R72161MB0R72162026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50884908183912SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908183943SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908187620SLX Hemo-Cath®Medical Components, Inc.LFJ2026-03-21
50884908187637SLX HEMO-CATH®Medical Components, Inc.LFJ2026-03-21
00801902223036ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223043ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
00801902223050ARROWTELEFLEX INCORPORATEDLFJ2025-09-11
20801902212218ARROWTELEFLEX INCORPORATEDLFJ2025-04-04
20801902190370ARROWTELEFLEX INCORPORATEDLFJ2025-03-11
50884908175221SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175238SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175245SLX Hemo-Cath®Medical Components, Inc.LFJ2024-08-28
50884908175252SLX HEMO-CATH®Medical Components, Inc.LFJ2024-08-28
50884908175436Hemo-Cath®Medical Components, Inc.LFJ2024-05-11
50884908175443Hemo-Cath®Medical Components, Inc.LFJ2024-05-11
50884908175450Hemo-Cath®Medical Components, Inc.LFJ2024-05-11
50884908175467Hemo-Cath®Medical Components, Inc.LFJ2024-05-11
20801902212225ARROWTELEFLEX INCORPORATEDLFJ2023-06-27
20801902215202ARROWTELEFLEX INCORPORATEDLFJ2023-06-05
20801902215240ARROWTELEFLEX INCORPORATEDLFJ2023-06-05
20801902190165ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
20801902190219ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
20801902190226ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
20801902190233ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
20801902190363ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
20801902190509ARROWTELEFLEX INCORPORATEDLFJ2022-11-29
50884908163792SLX Hemo-Cath®Medical Components, Inc.LFJ2022-03-18
50884908163808SLX Hemo-Cath®Medical Components, Inc.LFJ2022-03-18
50884908163815SLX Hemo-Cath®Medical Components, Inc.LFJ2022-03-18
50884908163822SLX Hemo-Cath®Medical Components, Inc.LFJ2022-03-18