FDA.reportPublic FDA data

INFINITI

Primary DI
10705032026369
Brand
INFINITI
Company
CORDIS CORPORATION
Model
CP0295
Catalog number
CP0295
Device description
MULTIPACK INF 5 JL4, JR4, CSI
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC
OESCardiac Catheterization Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
OESCardiac Catheterization KitCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9708540005 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETERCordis Corp.1997-09-30DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032026366PackageGS110In Commercial Distribution
10705032026369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503202636620705032026366
1070503202636910705032026369

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
Premarket exempt
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
10705032000512AVANTI+402604T402604T2016-08-01
10705032000550AVANTI402605R402605R2016-08-01
10705032000772AVANTI+402611T402611T2016-08-01
10705032009751AVANTI504404X504404X2016-08-01
10705032009782AVANTI504407X504407X2016-08-01
10705032009805AVANTI504409X504409X2016-08-01
10705032009812AVANTI504504S504504S2016-08-01
10705032009829AVANTI504505S504505S2016-08-01
10705032009836AVANTI504505X504505X2016-08-01
10705032009843AVANTI504506S504506S2016-08-01
10705032009850AVANTI504506X504506X2016-08-01
10705032009867AVANTI504507X504507X2016-08-01
10705032009874AVANTI504508X504508X2016-08-01
10705032009928AVANTI504604T504604T2016-08-01
10705032009973AVANTI504605T504605T2016-08-01
10705032010009AVANTI504606D504606D2016-08-01
10705032010016AVANTI504606P504606P2016-08-01
10705032010023AVANTI504606S504606S2016-08-01
10705032010030AVANTI504606T504606T2016-08-01
10705032010054AVANTI504606X504606X2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527436HalyardAVID MEDICAL, INC.OES2026-07-17
10198956335523CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956509283CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956524880CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529083CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529410CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10809160527252HalyardAVID MEDICAL, INC.OES2026-07-16
10198956478107CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956518131CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956526983CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956528208CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10809160526859HalyardAVID MEDICAL, INC.OES2026-07-08
10198956463400CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10198956525993CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10809160526361HalyardAVID MEDICAL, INC.OES2026-06-26
10841156112035LANGSTONTELEFLEX INCORPORATEDDQO2026-06-26
10809160526262HalyardAVID MEDICAL, INC.OES2026-06-25
10809160525937HalyardAVID MEDICAL, INC.OES2026-06-24
10809160525968HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526019HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526132HalyardAVID MEDICAL, INC.OES2026-06-24
10198956415553CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-23
10809160525869HalyardAVID MEDICAL, INC.OES2026-06-23
10809160525890HALYARDAVID MEDICAL, INC.OES2026-06-23
10809160525234HalyardAVID MEDICAL, INC.OES2026-06-22
10809160525555HalyardAVID MEDICAL, INC.OES2026-06-22
10809160525579HalyardAVID MEDICAL, INC.OES2026-06-22
10809160523148HalyardAVID MEDICAL, INC.OES2026-06-09
10809160523193HalyardAVID MEDICAL, INC.OES2026-06-09
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08