FDA.report

Zenysis Dual Lumen Acute Dialysis Catheter

Primary DI
10801741109796
Brand
Zenysis Dual Lumen Acute Dialysis Catheter
Company
Bard Access Systems, Inc.
Model
A863200
Catalog number
A863200
Device description
Zenysis DL, 20cm PC Kit
Published
2016-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MPBCATHETER, HEMODIALYSIS, NON-IMPLANTED

Product Code Classifications

CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741109796PackageGS15In Commercial Distribution
20801741109793PackageGS110In Commercial Distribution
00801741109799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174110979610801741109796
2080174110979320801741109793
00801741109799008017411097998017411097990801741109799

GMDN Terms

TermDefinition
Haemodialysis catheterization kitA collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access 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 includes a nonimplantable double-lumen haemodialysis catheter, device dedicated to catheter introduction/function (e.g., introducer needle, guidewire) and includes non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge11French
Length20Centimeter

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
10801741231343CentroVena One1MB0R72201MB0R72202026-01-23
10801741231350CentroVena One1MB0R73161MB0R73162026-01-23
10801741231367CentroVena One1MB0R73201MB0R73202026-01-23
10801741231374CentroVena One1MB0R73301MB0R73302026-01-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20801902225515ARROWTELEFLEX INCORPORATEDMPB2026-03-11
20801902222255ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222262ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222279ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222293ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222309ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222316ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222248ARROWTELEFLEX INCORPORATEDMPB2025-06-10
20801902221920ARROWTELEFLEX INCORPORATEDMPB2025-05-13
50884908182892DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182908DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182915DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182922DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182939DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182946DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182953DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182977DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182984DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182991DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183004DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183011DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183028DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183035DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183042DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183059DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183066DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183073DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183080DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183097DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182960DUO-FLOW®Medical Components, Inc.MPB2025-05-06