ON-Q* Pain Relief System

Basic Information

• Brand Name: ON-Q* Pain Relief System
• Primary DI: 00193494450991
• Version / Model: 45099
• Catalog Number: PS12506-A-N
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-08
• Public Version: 2
• Public Version Date: 2023-06-23
• Public Version Status: Update
• Public Device Record Key: 592c3c16-c0d9-45e8-8f15-915429fd6830

Device Description

ON-Q* Fixed Flow Pump Kits With ON-Q* SilverSoaker* Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• 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
47209	Hyaluronic acid (HA) IVD, kit, binding assay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of hyaluronic acid (HA) in a clinical specimen, using a binding assay.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10193494450998	GS1	CS	5	In Commercial Distribution
Primary	00193494450991	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063530	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Balloon Fill Volume (ml)
Total Volume	400	Milliliter