BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avanos Medical, Inc.

    Reg #: 3011270181 · FEI: 3011270181 · Expires 2026
    View on FDA
    Products
    61
    Proprietary Names
    218
    Establishment Types
    3
    Classifications
    61

    Registration Details

    Registration Name
    Avanos Medical, Inc.
    Registration Number
    3011270181
    FEI Number
    3011270181
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5405 Windward Parkway
    City
    Alpharetta
    State
    GA
    ZIP
    30004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111355
    PMA Number
    P140005

    Owner / Operator

    Firm Name
    Avanos Medical, Inc.
    Operator Number
    2022573
    Address
    5405 Windward Parkway, --
    City
    Alpharetta
    State
    GA
    Postal Code
    30004
    Country
    US

    Products

    Device Name Product Code
    Toothbrush, Manual EFW
    Protector, Ostomy EXE
    Anesthesia Conduction Kit CAZ
    Probe, Radiofrequency Lesion GXI
    Enteral Syringes With Enteral Specific Connectors PNR
    Tray, Surgical, Ent MMO
    Tape, Measuring, Rulers And Calipers FTY
    Tube, Tracheal (W/Wo Connector) BTR
    Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration KDH
    Clamp HXD
    Tubes, Gastrointestinal (And Accessories) KNT
    Tube, Gastro-Enterostomy KGC
    Pump, Infusion, Elastomeric MEB
    Tube, Feeding FPD
    Catheter, Conduction, Anesthetic BSO
    Pump, Infusion FRN
    Syringe, Piston FMF
    Generator, Lesion, Radiofrequency GXD
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Forceps, Biopsy, Electric KGE
    Laparoscope, General & Plastic Surgery GCJ
    Endoscopic Cytology Brush FDX
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Percussor, Powered-Electric BYI
    Gown, Examination FME
    Snare, Flexible FDI
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Set, Administration, Intravascular FPA
    Table And Attachments, Operating-Room BWN
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Tube, Nasogastric BSS
    Acid, Hyaluronic, Intraarticular MOZ
    Accessories, Cleaning Brushes, For Endoscope MNL
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Catheter, Urethral GBM
    Catheter, Straight EZD
    Container, I.V. KPE
    Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use PYO
    Clamp, Non-Electrical FFN
    Evacuator, Bladder, Manually Operated FFD
    Bedding, Disposable, Medical KME
    Pump, Infusion, Pca MEA
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Stimulator, Nerve, Peripheral, Electric KOI
    Patient Personal Hygiene Kit NSB
    Catheter And Tip, Suction JOL
    Apparatus, Autotransfusion CAC
    Gastrointestional Tube Holder PLI
    Utensil, Eating ILC
    Non-Bronchoscopic Bronchoalveolar Lavage Catheter OYI
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Helicobacter Pylori LYR
    Dispenser, Liquid Medication KYX
    Catheters, Suction, Tracheobronchial BSY
    Massager, Powered Inflatable Tube IRP
    Pack, Hot Or Cold, Water Circulating ILO
    General Surgery Tray LRO
    Tape And Bandage, Adhesive KGX
    Syringe, Irrigating (Non Dental) KYZ
    Anesthesia Kit OFQ

    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 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 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 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 Game Ready Therapy System RF Cannula Radiopaque RF Cannula MIC-KEY and MIC Transgastric Jejunal feeding tubes MIC and MIC-KEY G-Tube and Extension Sets Plaster PMP Kits and Catheters NeoMed GravityPro Oral/Enteral Syringes NeoMed Sterile Oral/Enteral Syringes CORGRIP* SR NG/NI Tube Retention System ECHOBRIGHT Superlock Syringes Endoscope Cleaning Brush ENTRAL FEEDING TUBES AND ACCESSORIES CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELIEF Med4 Elite 220344 220343 220542 220472 220462 220513NR 220573 220508NR 220539 220481NZ 220541 220507 220528 220404 220513 220576 220466 220574 220481ANR 220509NR 220561 220316 220266MIL 220481ZNR 220342 220477 220537 220405 220509 220472NR 220471 220463 220563 220471NR 220575 220473NR 220481AUS 220568 220507NR 220562 220532 220577 220508 220560 220451 220473 220493 220490NR 220491NR 220489NR I-Flow Elastomeric Pump Silicone/non DEHP Pump

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device