IV Plus®

Basic Information

• Brand Name: IV Plus®
• Primary DI: 10892855000802
• Version / Model: N0601A
• Company Name: NEXUS MEDICAL, LLC
• Labeler DUNS: 169260325
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a2f67e17-25de-4d7b-ae6e-8e1b6c7cb75b
• Distribution End Date: 2017-04-26

Device Description

20mm Multi-Dose Vial Access Device

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
LHI	Set, I.V. Fluid Transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58510	Vial transfer spike	A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial’s sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial’s contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30892855000806	GS1		50	Not in Commercial Distribution	2017-04-26
Primary	10892855000802	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080976	000