FDA.reportPublic FDA data

CentroVena One

Primary DI
10801741234764
Brand
CentroVena One
Company
Bard Access Systems, Inc.
Model
1RC0R7316
Catalog number
1RC0R7316
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
OTC
false
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
10801741234764PackageGS15In Commercial Distribution
00801741234767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174123476410801741234764
00801741234767008017412347678017412347670801741234767

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
true
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
true
Sterilization required before use
false

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
00801741231308CentroVena 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