Product Overview

Jelco - 328500


Device Description

A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: FOZ

Device Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5200

Third Party Flag: Y

Medical Specialty: HO


Device Identifiers

Device Id: 30351688081937

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10351688081933

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX


Device Id: 10351688081933

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


Device Id: 50351688081931

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 30351688081937

Package Quantity: 200

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE


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