FDA.report

Centurion

Primary DI
00653160309508
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
ART505
Published
2017-05-04
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

Related Records

Contact Domains

Product Codes

CodeName
OESCardiac catheterization kit

Product Code Classifications

CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653160309508PackageGS15In Commercial Distribution
10653160309505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160309508006531603095086531603095080653160309508
1065316030950510653160309505

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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 typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
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 DIBrandModelCatalogPublished
00653160294248CenturionMNS101552016-11-11
00653160315974CenturionCIT66352018-04-09
00653160284218CenturionCIT59202017-03-03
00653160274882CenturionPE31802018-02-11
00653160389753CenturionDM485BDM485B2025-09-17
00653160389296CenturionBT235BBT235B2025-08-24
00653160389319CenturionCSS640ACSS640A2025-08-24
00653160389494CenturionDT23104DT231042025-08-24
00653160388992CenturionSUT14785ASUT14785A2025-08-18
00653160389357CenturionDT23103DT231032025-08-18
00653160389067CenturionDYNDV2722DYNDV27222025-08-09
00653160389074CenturionSUT19525ASUT19525A2025-08-09
00653160389159CenturionIVS1090BIVS1090B2025-08-09
00653160388978CenturionMNS10875BMNS10875B2025-08-02
00653160386936CenturionIVS4222IVS42222025-07-21
00653160388909CenturionSUT21465BSUT21465B2025-07-21
00653160388848CenturionDYNDC3166DDYNDC3166D2025-07-18
00653160388732CenturionSUT19955BSUT19955B2025-07-14
00653160388770CenturionDM875ADM875A2025-07-14
00653160388794CenturionSUT12485ASUT12485A2025-07-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10809160521847HalyardAVID MEDICAL, INC.OES2026-05-26
10198956478855CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956485457CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956486775CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956488618CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
20809160517236HalyardAVID MEDICAL, INC.OES2026-03-24
50198956364194CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956380385CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956415070CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956433234CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
20809160517120HalyardAVID MEDICAL, INC.OES2026-03-23
20809160516871HalyardAVID MEDICAL, INC.OES2026-03-20
20809160516895HalyardAVID MEDICAL, INC.OES2026-03-20
20809160516956HalyardAVID MEDICAL, INC.OES2026-03-20
50198956404272CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956410518CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956412826CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
40198459589899MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459594985MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611538MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611552MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611569MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611576MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459613556MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616618MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616625MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616632MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616649MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459619466MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459619770MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16