Avanos Medical, Inc.

FDA Device Registration & Listing · Alpharetta, GA, US · Registration 3011270181

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011270181
FEI Number
3011270181
Entity Name
Avanos Medical, Inc.
City/State/Country
Alpharetta, GA, US
Establishment Address
5405 Windward Parkway, Alpharetta, GA 30004, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Avanos Medical, Inc. (Owner Number: 2022573)
Owner / Operator Contact Address
5405 Windward Parkway, --, Alpharetta, GA 30004, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Toothbrush KimVent Oral Care SOFSWAB DENTASWAB Dentaswab Ace Stopper EchoBright Echogenic PNB Needle EchoLong Needle/Catheter Set EchoBright Echogenic Regional Block Needle with Injection Set ThoraCool Sinergy LumbarCool Transdiscal NeoConnect at Home Oral/Enteral Syringes with ENFit Connector BALLARD* Mini-BAL Prep Pack with Specimen Trap Radiofrequency Probe-Curved EASI-LAV enteral feeding tubes CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE MIC-KEY* ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP Ameritus Entral Feeding Tube Fenestrated Infusion Catheter Syringe I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) SELECT-A-FLOW* MIC-KEY "G" LOW PROFILE G MIC-KEY CORTRAK* 2 ENTERAL ACCESS SYSTEM PROLONG, MODELS PL50, PL100, PL150 ANTI-FOG KIT Endoscopic Accessories Cytology Brush SOAKER CATHETER Kimberly-Clark Microcuff 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) Baxter Tip Caps NeoConnect NeoSecure Syringe Tip Caps (for use with NeoConnect Oral/Enteral Syringes with ENFit Connector) MIC PEG Kit MIC PEG TUBE ambIT Introducer Fenestrated NeoDrape (Sterling Medical product) PreSet v1.5 PreSet PCA ambIT PreSet Pump NeoConnect PVC Enteral Feeding Tubes with ENFit Connector NeoMed PVC Enteral Feeding Tubes Minibore extension set Halyard Radiofrequency Probe Radiofrequency Generator Connector Cable Radiofrequency Probe Kit-Curved Radiofrequency Bipolar Adapter Radiofrequency Probe Kit-Straight COOLIEF* Cooled Radiofrequency Kit COOLIEF* Multi-Cooled Radiofrequency Kit COOLIEF* SInergy* Cooled Radiofrequency Kit COOLIEF* Fluid Delivery Introducer NeoMed Polyurethane Feeding Tubes NeoConnect Polyurethane Enteral Feeding Tubes with ENFit connector NeoConnect Silicone Enteral Feeding Tubes with ENFit Connector (Footprint Medical) NeoMed Silicone Enteral Feeding Tubes GenVisc 850 Sodium Hyaluronate PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS CORTRAK* 2 Equilateral Enteral Access System 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 KimVent Microcuff NeoMed Urinary Catheter Container, IV NERVE BLOCK INFUSION KIT CORFLO* PEG Pinch Clamps ENTERAL DRAINAGE BAG NeoDrape ON-Q* Tunneler Introducer Sheaths ON-Q Tunnelers and Sheaths ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller ON-Q* NeoConnect Enteral Extension Set with ENFit connector NeoConnect Sampling Straw with ENFit Connector NeoMed Enteral Only Extension Set ambIT PCA Pump Prolong COOLIEF Radiofrequency Ablation System Coolief Radiofrequency Generator (CRG) System Single Shot Tray Products or Continuous Tray Products EZstim* CORFLO* PEG Kit MIC LOW PROFILE GASTROSTOMY TUBE cleaning, non-sterile Split Dispersive Electrode Grounding Pad Yankauer 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* Prolong CORFLO* PEG Silicone Fixation Device CORFLO* PEG Fixation Device Base and Cover NeoMed Sampling Straw lavage catheter 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 ambIT Continuous infusion pump Gastropexy Kit and Dilator CORTRAK* 2 Equilateral Enteral Access System 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 CLOtest NeoConnect DoseMate DL Oral Administration Tip NeoMed Transfer Lid NeoConnect Pharmacy Bottle Caps NeoConnect DoseMate Oral Administration Tip NeoConnect Syringe-to-Syringe Coupler NeoMed NeoBottle NeoMed Fill Cap Coupler Pharmacy Pack Oral Syringes NeoMed Oral Syringe-to-syringe Coupler Baxter Pharmacy Bottle Caps NeoMed Colostrum and Breastmilk Container with Transfer Lid TriVisc ProBloc, HN Series and Prolong, PL Series AVANOS* Universal Block Trays HOMEPUMP ECLIPSE* ON-Q Pain Relief System with Bolus ON-Q* Pump SELECT-A-FLOW* Halyard TRACH CARE TRACHEAL SUCTION SYSTEM KimVent Closed Suction System BALLARD Liberator/Restore Ballard Single Dose Vials, 0.9% Sodium Chloride Solution Ballard Metered Dose Inhaler (MDI) Adapter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFW Toothbrush, Manual Dental Class 1 872.6855 2014-10-13
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2017-05-31
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2013-11-11
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
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2020-03-02
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2014-10-13
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2014-10-13
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2014-10-15
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Gastroenterology, Urology Class 2 876.5980 2006-04-11
HXD Clamp General, Plastic Surgery Class 1 878.4800 2014-10-14
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-07-06
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-06-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-09-19
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2008-03-12
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-09-19
MEB Pump, Infusion, Elastomeric General Hospital Class 2 880.5725 2013-11-08
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2021-12-09
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2016-10-05
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2016-10-05
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-12-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-10-31
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2014-10-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-10-14
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2014-10-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2014-08-01
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2014-10-13
MEB Pump, Infusion, Elastomeric General Hospital Class 2 880.5725 2013-11-08
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2006-04-11
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-09-17
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2013-11-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2006-08-07
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2014-10-15
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2014-10-15
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2013-11-08
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2010-03-08
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2017-07-06
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2020-01-28
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2020-01-28
BYI Percussor, Powered-Electric Anesthesiology Class 2 868.5665 2014-10-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-05-08
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2022-08-03
FME Gown, Examination General Hospital Class 1 880.6265 2003-03-12
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2019-01-30
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-12-16
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-01-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-09-19
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2014-10-15
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2014-10-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-02
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2014-10-13
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2014-10-13
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2016-12-21
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-07-06
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2017-09-19
BSS Tube, Nasogastric Gastroenterology, Urology Class 2 876.5980 2020-01-28
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2020-01-28
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2014-12-16
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2014-10-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-10-13
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2020-01-28
MOZ Acid, Hyaluronic, Intraarticular Unknown Class 3 N/A 2022-02-18
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2014-10-15
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2013-11-08
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2014-10-15
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2014-10-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-02-25
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2013-11-11
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2010-03-08
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2020-01-28
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2020-01-28
KPE Container, I.V. General Hospital Class 2 880.5025 2022-02-16
MEB Pump, Infusion, Elastomeric General Hospital Class 2 880.5725 2013-11-08
PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use General Hospital Class 1 880.5240 2022-09-30
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-09-19
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2013-11-11
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2020-04-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-10-13
FFD Evacuator, Bladder, Manually Operated Gastroenterology, Urology Class 1 876.4370 2017-05-30
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2003-07-24
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2013-11-08
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-01-28
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2021-12-16
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2013-11-11
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2024-09-25
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2020-04-14
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2020-04-14
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2014-10-15
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2012-01-25
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2014-08-01
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2017-05-17
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2016-12-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2014-08-01
NSB Patient Personal Hygiene Kit Dental Class 1 872.6855 2023-04-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-07-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-09-19
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2014-10-13
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2013-11-08
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2013-11-11
PLI Gastrointestional Tube Holder Gastroenterology, Urology Class 2 876.5980 2020-04-30
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2014-11-21
ILC Utensil, Eating Physical Medicine Class 1 890.5050 2020-01-28
OYI Non-Bronchoscopic Bronchoalveolar Lavage Catheter Anesthesiology Class 1 868.6810 2023-04-25
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
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-12-16
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2010-01-15
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2017-09-08
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-05-20
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2021-02-05
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2007-12-10
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2020-01-28
MOZ Acid, Hyaluronic, Intraarticular Unknown Class 3 N/A 2022-02-18
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2013-11-08
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2007-08-14
MEB Pump, Infusion, Elastomeric General Hospital Class 2 880.5725 2020-02-26
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2007-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9680425 Avent S. de R.L. de C.V. TIJUANA Baja California, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-06 VIASYS Med Systems 2
Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0002-06 VIASYS Med Systems 2
Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0033-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04 VIASYS Med Systems 1
Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04 VIASYS Med Systems 1
Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166
Z-0038-04 VIASYS Med Systems 1
Sideport Kit w/Oxygen Line, consisting of an adjustable sideport valve, an O2 port elbow and O2 supply tubing; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83167

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