- Physicians Office Resource

CELSITE ST501H ST SET PUR8.5F IV USA
CELSITE - 5437026

Device Description

A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.

Environmental Conditions

Special Storage Condition, Specify

KEEP DRY

Special Storage Condition, Specify

Store at room temp

Special Storage Condition, Specify

Keep away from sunlight

Special Storage Condition, Specify

Avoid extreme temperature

Device Sizes

Catheter Gauge: 8.50 French

Septum Diameter : 12.000 MM

Catheter Gauge: 8.50 French
Septum Diameter : 12.000 MM

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LJT

Device Name: Port & Catheter, Implanted, Subcutaneous, Intravascular

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: Y

Target Area: N/A

Regulation Number: 880.5965

Third Party Flag: N

Medical Specialty: HO

Device Identifiers

Device Id: 04046963595111

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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