FDA.reportPublic FDA data

Power-Trialysis Slim-Cath catheter

Primary DI
00801741107245
Brand
Power-Trialysis Slim-Cath catheter
Company
Bard Access Systems, Inc.
Model
5853200
Catalog number
5853200
Device description
12Fr Trialysis ST 20cm Kit
Published
2015-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIECATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIECatheter, Hemodialysis, Triple Lumen, Non-ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741107242PackageGS15In Commercial Distribution
20801741107249PackageGS110In Commercial Distribution
00801741107245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174110724210801741107242
2080174110724920801741107249
00801741107245008017411072458017411072450801741107245

GMDN Terms#

Term, Definition table
TermDefinition
Triple-lumen haemodialysis catheterA sterile, flexible, triple-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access to: 1) conduct blood from a patient and return it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enable central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes three lumens, two dedicated to coaxial flow of blood for dialysis, and the third intended for independent IV access. Devices dedicated to catheter introduction/function may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Device Size Text, specify0
Length20Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741240034PowerPICC SOLOCK001093CK0010932026-05-27
00801741240041PowerPICC Provena SOLOCK001094CK0010942026-05-27
00801741240058PowerPICC Provena SOLOCK001095CK0010952026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001096CK0010962026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001097CK0010972026-05-27
10801741082983StatLockS04020010S040200102025-05-02
10801741087582StatLockD05000002AD05000002A2025-05-02
10801741188852StatLockSEC2404320SEC24043202020-04-22
10801741188869StatLockSEC2404321SEC24043212020-04-22
00801741075452SecurisSEC0100SEC01002019-10-17
00801741081248StatLock068400047206840004722025-05-02
00801741081255StatLock068400049306840004932025-05-02
00801741081521STATLOCKCV0223CV02232023-11-09
00801741081552STATLOCKCV0226CV02262023-11-09
00801741081576STATLOCKCV0321CV03212023-11-09
00801741081675STATLOCKIB0200IB02002023-11-09
00801741081682STATLOCKIV0220IV02202023-11-09
00801741081750STATLOCKIV0500IV05002023-11-09
00801741081767STATLOCKIV0501IV05012023-11-09
00801741081897STATLOCKIV0528IV05282023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741238062PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238079PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238086PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238093PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238109PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238116PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238130PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238147PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238253Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238260Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238277Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238284Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238291Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238307Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238314Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238321Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238413PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238420PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238437PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238444PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238451PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238468PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238475PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238482PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
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