FDA.report

INFINITI

Primary DI
20705032013786
Brand
INFINITI
Company
CORDIS CORPORATION
Model
534531T
Catalog number
534531T
Device description
CATH F5 INF SON II 80CM 4SH
Published
2016-08-01
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

Product Codes

CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20705032013786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2070503201378620705032013786

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damanged
Special Storage Condition, Specify00Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
Special Storage Condition, Specify00Store in cool, dark, dry place
Special Storage Condition, Specify00To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter

Sterilization Methods

Method

Regulatory Flags

DUNS number
806136177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
false
Sterilization required before use
false

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