ON-Q* Pain Relief System

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name: ON-Q* Pain Relief System FDA UDI
Generic Name: Cardiac pulse generator software FDA UDI
Device Name: ON-Q* Fixed Flow Pump Kits With ON-Q* Soaker* Catheter FDA UDI
Model / Reference: 45082 FDA UDI
Description: ON-Q* Fixed Flow Pump Kits With ON-Q* Soaker* Catheter FDA UDI

Identifiers

Catalog Number: PS6508-N FDA UDI
Primary DI / UDI-DI: 00193494450823 FDA UDI
510(k) Number: K063530 FDA UDI
FDA Product Code: MEB FDA UDI
GMDN Term: Cardiac pulse generator software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 400 Milliliter FDA UDI

Category: Cardiac pulse generator software

ON-Q* Pain Relief System by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac pulse generator software.

LATITUDE Consult™ — Boston Scientific · Class III
LATITUDE Consult™ — Boston Scientific · Class III

Cleared under the same submission

K063530 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Avanos Medical, Inc.

Sources (1)

FDA UDI 41eaa4d4-3df1-4fec-a4ab-5031b27be9e1 37 fields · synced Jun 9, 2026