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ON-Q* Pain Relief System 47606

by Avanos Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30680651476068 UDI-DI Date17 Nov 2018ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-2860-2011 FDA Unclassified (pre-2012) initiated 15 Apr 2011

    The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.

    • Terminated Z-2133-2008 FDA Unclassified (pre-2012) initiated 14 Feb 2008

    Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.

    • Terminated Z-1869-2008 FDA Unclassified (pre-2012) initiated 12 Feb 2008

    The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ON-Q* Pain Relief System
Generic Name
Extremity-oxygenation hyperbaric chamber, non-powered
Model / Ref / Catalog
47606, CB004-D
Primary DI / UDI-DI
30680651476068
510(k) Number
FDA Product Code
MEB
GMDN Term
Extremity-oxygenation hyperbaric chamber, non-powered
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
In Commercial Distribution

Related devices

Category: Extremity-oxygenation hyperbaric chamber, non-powered

Cleared under the same submission (K063530)

Show all (12)

Other devices from Avanos Medical, Inc.

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Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (6)

  • Implantable: No
  • Over-the-Counter: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No