Invisiport 4.4 Fr

Basic Information

• Brand Name: Invisiport 4.4 Fr
• Primary DI: 00864144000209
• Version / Model: 2000
• Catalog Number: 2000
• Company Name: STEALTH THERAPEUTICS, INC.
• Labeler DUNS: 963281709
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-19
• Public Version: 4
• Public Version Date: 2020-02-27
• Public Version Status: Update
• Public Device Record Key: 244d1669-9655-4942-a22a-48ef8a836faa
• Distribution End Date: 2018-09-11

Device Description

Invisiport 4.4 Fr Convenience Kit Contents: Invisiport 4.4Fr Vascular Access Port with Catheter (Not made with natural rubber latex); Microaccess Tear-Away Introducer Set; MicroIntroducer needle; Microguidewire; 20 Gauge, 1.5 inch, Non-Coring Access Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
16858	Catheter injection port	A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864144000209	GS1

Customer Contacts

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