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ON-Q* Pain Relief System with SOAKER* Catheter, NRFit™ Connector PS25006-N

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 Number00193494000097 UDI-DI Date23 Jun 2023ListedStatusListed 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  • Withdrawn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 with SOAKER* Catheter, NRFit™ Connector
Generic Name
Gas chromatography analyser column IVD
Model / Ref / Catalog
PS25006-N
Primary DI / UDI-DI
00193494000097
510(k) Number
FDA Product Code
MEB
GMDN Term
Gas chromatography analyser column IVD
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gas chromatography analyser column IVD

Cleared under the same submission (K063530)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No