Lifeport

Basic Information

• Brand Name: Lifeport
• Primary DI: H787LPS72550
• Version / Model: LPS7255
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-07
• Public Version: 4
• Public Version Date: 2021-11-30
• Public Version Status: Update
• Public Device Record Key: 492bf696-f406-4df8-956e-53ab747d882f
• Distribution End Date: 2021-11-23

Device Description

Lifeport Dual Low Profile Plastic Port System with Attachable Dual Lumen 6.6F x 76cm Polyurethane Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJT	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR	General Hospital	880.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61494	Vascular port/catheter	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H787LPS72550	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K953529	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18	Gauge
Length	76	Centimeter
Outer Diameter	2.2	Millimeter
Lumen/Inner Diameter	1	Millimeter
Catheter Gauge	6.6	French