Onset

Basic Information

• Brand Name: Onset
• Primary DI: 00860001977356
• Version / Model: 41938-03
• Company Name: Onpharma Company
• Labeler DUNS: 081037594
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-19
• Public Version: 1
• Public Version Date: 2025-09-29
• Public Version Status: New
• Public Device Record Key: 250ec1fe-f7f9-4a68-b8d2-a382e95f9cab

Device Description

Onset EZ™ Buffering Pen, 2.8-3.0mL volume, single pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEP	System/Device, Pharmacy Compounding	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. 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	00860001977356	GS1

Customer Contacts

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