Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680425

FEI Number

3007596547

Entity Name

Avent S. de R.L. de C.V.

City/State/Country

TIJUANA Baja California, MX

Establishment Address

Ave Noruega Edificio D-1B, Fraccionamiento, Rubio, TIJUANA Baja California 22116, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Avanos Medical, Inc. (Owner Number: 2022573)

Owner / Operator Contact Address

5405 Windward Parkway, --, Alpharetta, GA 30004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143164

PMA Number

N/A

All Registered Proprietary Names

I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) SELECT-A-FLOW* ON-Q* PAIN RELIEF SYSTEM CONVENIENCE KIT WITH SELECT-A-FLOW* ambIT Introducer Radiofrequency Probe-Curved Baxter Enteral Syringe with ENFit Connector NeoConnect Oral/Enteral Syringes with ENFit connectors (12ml to 100ml) NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connectors (0.5mL to 6mL) COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced COOLIEF* Cooled Radiofrequency Kit Advanced COOLIEF* Cooled Radiofrequency Probe Advanced COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer COOLIEF* Multi-Cooled Radiofrequency Kit Advanced Coolief Radiofrequency Generator (CRG) System SOAKER CATHETER ON-Q CATHETER, ON-Q ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER ON-Q* Antimicrobial Expansion Kits with SILVERSOAKER* Catheter ON-Q* ANTIMICROBIAL EXPANSION-Q KITS WITH SILVERSOAKER* ANTIMICROBIAL CATHETER AND NRFit" CONNECTOR ON-Q* BD Epilor Plastic LOR 7 mL with luer slip tip syringe PMP Kits and Catheters RF Cannula Radiopaque RF Cannula CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELIEF ProBloc, HN Series and Prolong, PL Series CORFLO* PEG Kit MIC LOW PROFILE GASTROSTOMY TUBE PROLONG, MODELS PL50, PL100, PL150 PreSet v1.5 PreSet PCA ambIT PreSet Pump Game Ready Therapy System Radiofrequency Probe Radiofrequency Generator Connector Cable Radiofrequency Probe Kit-Curved Radiofrequency Bipolar Adapter Radiofrequency Probe Kit-Straight CORFLO* PEG Pinch Clamps ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP ON-Q* Tunneler Introducer Sheaths ON-Q Tunnelers and Sheaths ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller ON-Q* HOMEPUMP ECLIPSE* ON-Q Pain Relief System with Bolus ON-Q* Pump SELECT-A-FLOW* PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS EchoBright Echogenic PNB Needle EchoLong Needle/Catheter Set EchoBright Echogenic Regional Block Needle with Injection Set CORPAK ENTERAL Y EXTENSION SET RECORDER KIDS PIB PIB IL ambIT PIEB ambIT PIB ambIT PIB*PCA ambIT PCA*PIB PCA Pump Remote Bolus Button Switch ambIT Programmable Intermittent Pump ambIT PIB/PCA v 1.5 PERIPHERAL NERVE BLOCK SUPPORT TRAY ON-Q* Pain Relief System T-Bloc* Continuous Echogenic Stimulating Nerve Block Tray ON-Q* Pain Relief System T-Bloc* Ultrasound Nerve Block Prep Tray ON-Q* Pain Relief System T-Bloc* Echogenic Stimulating Needle/Catheter Set ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC STIMULATING NERVE BLOCK TRAY WITH NRFit CONNECTOR ON-Q* PAIN RELIEF SYSTEM T-BLOC* ECHOGENIC STIMULATING NEEDLE/CATHETER SET WITH NRFit CONNECTOR ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC NERVE BLOCK WITH NRFit CONNECTOR ON-Q* PAIN RELIEF SYSTEM T-BLOC* ULTRASOUND NERVE BLOCK PREP TRAY WITH NRFit CONNECTOR ON-Q* Pain Relief System T-Bloc* Echogenic Needle/Catheter Set ON-Q* Pain Relief System T-Bloc* Needle/Catheter Set anesthesia conduction kit - ON-Q* Pain Relief System T-Bloc* Continuous Echogenic Nerve Block Tray ECHOBRIGHT Prolong Med4 Elite I-Flow Elastomeric Pump Silicone/non DEHP Pump Prolong MIC PEG Kit MIC PEG TUBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2013-11-08
OJG	Neurological Tray	Neurology	Class 1	882.4525	2018-11-12
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2022-08-03
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2014-10-13
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2020-01-28
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2021-02-05
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2020-04-14
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2020-04-14
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2016-10-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2016-10-05
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2013-11-08
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2013-11-08
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-07-03
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-08-14
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2014-10-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2013-11-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-09-19
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2013-11-08
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2014-10-13
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-08-01
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2014-10-15
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-09-19
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2013-11-08
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-12-16
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2021-03-25
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2021-03-25
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2014-10-13
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2020-04-30
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2013-11-08
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2008-05-08
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2013-11-08
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2020-02-26
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2013-11-08
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2013-11-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2021-12-10
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-12-16
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2021-12-16
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2013-11-11
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2013-11-11
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2013-11-11
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2021-02-26
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2021-02-26
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2020-02-26
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2013-11-11
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2017-09-19
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-05-08
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2014-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

Amy Winegarden Business: Avanos Medical, Inc. Email: RegulatoryAffairsNA@avanos.com Phone: (844) 4282667

Related Public Records

Same Entity

Avanos Medical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611594	AVENT S. de R.L. de C.V.	NOGALES Sonora, MX
3011270181	Avanos Medical, Inc.	Alpharetta, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27
K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe	2021-06-28
K020354	Baylis Medical Co., Inc.	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	2002-05-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680425. Last updated year: 2026. Please use registration number 9680425 when referencing this establishment in official correspondence.