OnGuard2 Syringe Adaptor, 5 Units

Basic Information

• Brand Name: OnGuard2 Syringe Adaptor, 5 Units
• Primary DI: 27290115921889
• Version / Model: 412188
• Company Name: SIMPLIVIA HEALTHCARE LTD
• Labeler DUNS: 521161349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 75
• Record Status: Published
• Publish Date: 2024-09-08
• Public Version: 1
• Public Version Date: 2024-09-16
• Public Version Status: New
• Public Device Record Key: 735e800f-84ff-480b-85ed-01ede7d5aa3a

Device Description

OnGuard2 Syringe Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to Chemfort port (e.g., Vial Adaptor) The device Proximal end is intended to connect to luer syringe

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
Package	37290115921886	GS1		6	In Commercial Distribution
Primary	27290115921889	GS1
Unit of Use	17290115921882	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192866	000