ON-Q* Pain Relief System

Basic Information

• Brand Name: ON-Q* Pain Relief System
• Primary DI: 30680651476440
• Version / Model: 47644
• Catalog Number: CB004-RB
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-03
• Public Version: 2
• Public Version Date: 2023-06-23
• Public Version Status: Update
• Public Device Record Key: 64df6637-abd8-4bff-a2f0-3be3ff10e91b

Device Description

ON-Q* Pain Relief System Convenience Kit with SELECT-A-FLOW*, 400 ml, 2-14 ml/hr

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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
MEB	Pump, infusion, elastomeric	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47189	Extremity-oxygenation hyperbaric chamber, powered	A small, mains electricity (AC-powered) device intended to hermetically surround a patient's limb for the topical application of oxygen (O2) from a O2 supply, usually humidified, at a pressure slightly greater than atmospheric (e.g., 1 to 2 atm) during hyperbaric oxygen therapy (HBOT). The O2-enriched atmosphere may be raised above normal pressure by the device either continuously or intermittently. The device is typically a rigid plastic shell with electronic controls or a flexible shell connected to controls, tubing, and other accessories. It is typically used to treat skin ulcerations, decubitus ulcers, infected stumps, skin grafts, burns, and frostbite.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30680651476440	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063530	000