IV Plus®

Basic Information

• Brand Name: IV Plus®
• Primary DI: 10815879020908
• Version / Model: HS07519
• Company Name: STAR MOUNTAIN MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 080490186
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-10
• Public Version: 7
• Public Version Date: 2020-02-26
• Public Version Status: Update
• Public Device Record Key: 7f339c1f-64bc-45f9-b798-606b0cfadbca
• Distribution End Date: 2019-08-01

Device Description

19 Ga. X 0.75 in. (1.1 mm X 19 mm)

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30815879020902	GS1		25	Not in Commercial Distribution	2019-08-01
Primary	10815879020908	GS1

Customer Contacts

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