FDA.reportPublic FDA data

Centurion

Primary DI
00653160350067
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
CVI3505
Catalog number
CVI3505
Device description
VASCULAR ACCESS BUNDLE
Published
2022-01-14
Public version status
New
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
K212258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212258000Medline Cardiovascular Procedure KitMedline Industries, Inc.2021-12-03LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160350067PackageGS15In Commercial Distribution
10653160350064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160350067006531603500676531603500670653160350067
1065316035006410653160350064

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method

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
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956346369CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956348950CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956363922CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956386099CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956390928CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956391437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956399945CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956427693CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956434004CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956439436CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956441934CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956444119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956463035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956470071CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956471306CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956474703CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956477049CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956477759CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956478077CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956480841CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956482012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956486683CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489318CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489844CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956490062CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956490383CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956490550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956492417CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956492844CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03