FDA.reportPublic FDA data

CentroVena One

Primary DI
00801741231308
Brand
CentroVena One
Company
Bard Access Systems, Inc.
Model
1K0R7316
Catalog number
1K0R7316
Device description
CentroVena One™ Insertion System Central Venous Catheter
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SEFCentral venous catheter with manual insertion system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SEFCentral Venous Catheter With Manual Insertion SystemGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741231305PackageGS15In Commercial Distribution
00801741231308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174123130510801741231305
00801741231308008017412313088017412313080801741231308

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7French
Length16Centimeter

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
No natural rubber latex
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
00801741231278CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231285CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231315CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231322CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231339CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231346CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231353CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231360CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231377CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231384CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231391CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231407CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231414CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231421CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231438CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231445CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231452CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231469CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231476CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231483CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231490CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231506CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231513CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741231520CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741234699CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741234705CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741234712CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741234729CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741234736CentroVena OneBard Access Systems, Inc.SEF2026-01-23
00801741234743CentroVena OneBard Access Systems, Inc.SEF2026-01-23