Product Overview

Jelco - 448211


Device Description

A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. 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: 55019315118560

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019315118566

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Pallet


Device Id: 35019315118566

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315118562

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case


Device Id: 15019315118562

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


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