OnGuard®2 20mm Vial Adaptor II and 13mm convertor

Basic Information

• Brand Name: OnGuard®2 20mm Vial Adaptor II and 13mm convertor
• Primary DI: 27290115921711
• Version / Model: 412171
• Company Name: SIMPLIVIA HEALTHCARE LTD
• Labeler DUNS: 521161349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2024-09-15
• Public Version: 1
• Public Version Date: 2024-09-23
• Public Version Status: New
• Public Device Record Key: a65e7c6b-64d9-485a-9c07-61af07c193a9

Device Description

OnGuard2 20mm Vial Adaptor is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck drug vial The device proximal end is intended to connect to OnGuard2 Syringe Adaptor / Syringe Adaptor Lock

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
Unit of Use	17290115921714	GS1
Primary	27290115921711	GS1
Package	37290115921718	GS1		4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192866	000