FDA.reportPublic FDA data

Centurion

Primary DI
10653160387657
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
CVI4510
Catalog number
CVI4510
Device description
CATHETERLESS INSERTION KIT
Published
2025-05-12
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213481000Medline General Surgery TrayMedline Industries, Inc.2022-05-24LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160387650PackageGS15In Commercial Distribution
10653160387657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160387650006531603876506531603876500653160387650
1065316038765710653160387657

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
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
10653160395980CENTURIONIV8885BIV8885B2026-10-29
10653160277361CenturionECT18234SCST2017-06-30
10653160309505CenturionART5052017-05-04
10653160319863CenturionSTCVC172018-08-17
10653160319870CenturionSTCVC182018-08-17
10653160319917CenturionSTCVC192018-08-17
10653160319924CenturionSTCVC202018-08-17
10653160319931CenturionSTCVC212018-08-17
10653160319948CenturionCVI3535A2018-08-17
10653160319986CenturionSTCVC222018-08-18
10653160321194CenturionCVI45102018-10-04
10653160324591CenturionART8852019-02-10
10653160326557CenturionART9052019-05-05
10653160327738CenturionGW1850IGW1850I2020-05-18
10653160330868CenturionECVC7165ECVC71652019-10-31
10653160330974CenturionCVI4650CVI46502019-11-04
10653160338239Medline Industries, Inc.STCVC18STCVC182020-01-02
10653160338253Medline Industries, Inc.STCVC17STCVC172020-01-02
10653160339038Medline Industries, Inc.STCVC22STCVC222020-01-22
10653160339052Medline Industries, Inc.STCVC21STCVC212020-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956323209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
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10198956546035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956548817CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956561335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956575264CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956575905CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956577251CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956577657CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956584440CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956586161CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956586338CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956589179CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956589650CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956591080CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956591868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956593213CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956595460CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956596221CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956598744CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956600102CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956603059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956605046CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607118CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607125CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607958CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956608528CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956609815CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956609990CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29