OnGuard Spike Port Adaptor

Basic Information

• Brand Name: OnGuard Spike Port Adaptor
• Primary DI: 37290115921138
• Version / Model: 412113
• Company Name: SIMPLIVIA HEALTHCARE LTD
• Labeler DUNS: 521161349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-10-03
• Public Version: 1
• Public Version Date: 2022-10-11
• Public Version Status: New
• Public Device Record Key: fe6ea7b9-523b-408a-a3eb-5f679893fb1b

Device Description

The Spike Port Adaptor is part of the OnGuard CSTD system. The devices spike connects to IV solution container. The proximal end connects to IV set spike, to allow administration. The port connects to OnGuard2 Syringe Adaptor to transfer drug or withdraw saline / drug.

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
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41222	Medication transfer set	A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	37290115921138	GS1
Unit of Use	17290115921134	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141448	000