OnGuard 2 CSTD Bag Adaptor SP with ULTRASITE

Basic Information

• Brand Name: OnGuard 2 CSTD Bag Adaptor SP with ULTRASITE
• Primary DI: 37290115921466
• Version / Model: 412146
• Company Name: SIMPLIVIA HEALTHCARE LTD
• Labeler DUNS: 521161349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• Record Status: Published
• Publish Date: 2021-03-11
• Public Version: 1
• Public Version Date: 2021-03-19
• Public Version Status: New
• Public Device Record Key: 8cfbb9ec-9125-4acd-b121-d77a143d2958

Device Description

A Chemfort CSTD Product

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: Yes
• 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	17290115921462	GS1
Primary	37290115921466	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201142	000