BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Salter Labs

    Reg #: 3004748541 · FEI: 3004748541 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    119
    Establishment Types
    3
    Classifications
    33

    Registration Details

    Registration Name
    Salter Labs
    Registration Number
    3004748541
    FEI Number
    3004748541
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    30 Spur Drive
    City
    El Paso
    State
    TX
    ZIP
    79906
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121743

    Owner / Operator

    Firm Name
    SunMed "also trading as AirLife"
    Operator Number
    9038422
    Address
    2710 Northridge Drive NW, Suite A
    City
    Grand Rapids
    State
    MI
    Postal Code
    49544
    Country
    US
    Correspondent
    Rob Yamashita

    Products

    Device Name Product Code
    Stimulator, Nerve, Battery-Powered BXN
    Laryngoscope, Rigid CCW
    Nebulizer (Direct Patient Interface) CAF
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Cannula, Nasal, Oxygen CAT
    Ventilator, Non-Continuous (Respirator) BZD
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Mask, Oxygen, Non-Rebreathing KGB
    Mask, Oxygen BYG
    Tube, Tracheal (W/Wo Connector) BTR
    Spirometer, Diagnostic BZG
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Meter, Peak Flow, Spirometry BZH
    Monitor, Breathing Frequency BZQ
    Drain, Tee (Water Trap) BYH
    Blood Pressure Cuff DXQ
    Stylet, Tracheal Tube BSR
    Infusor, Pressure, For I.V. Bags KZD
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Device, Fixation, Tracheal Tube CBH
    Ventilatory Effort Recorder MNR
    Spirometer, Therapeutic (Incentive) BWF
    Blanket, Neonatal Phototherapy PDH
    Mask, Oxygen, Low Concentration, Venturi BYF
    Tape And Bandage, Adhesive KGX
    Flowmeter, Calibration, Gas BXY
    Airway, Oropharyngeal, Anesthesiology CAE
    Ventilator, Continuous, Facility Use CBK
    Tubing, Pressure And Accessories BYX
    Connector, Airway (Extension) BZA
    Ventilator, Continuous, Non-Life-Supporting MNS
    Airway, Nasopharyngeal BTQ
    Conserver, Oxygen NFB

    Proprietary Names

    STIMULATOR, NERVE, BATTERY-POWERED IntuBrite Laryngoscope Salter Aire Elite Compressor (Apex Minitab) CO2 Comfort Soft Plus Cannula Utopia AV Double Lumen endobroncheal Tube, Parker Parker Standard Tip Endobronchial Tube Salter Labs Oxygen Mask - Non-rebreathing Salter Labs Elongated Style Adult and Pediatric Style Mask TwinMed -Mask Partial Non-Rebreather Westmed Masks Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff & Stylet (PFTVVCS) Salter Labs Trach-Vac Endotracheal Tube Trach-Vac Endotracheal Tube with Flex Tip (PFTVPUS) Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff (PFTVVC) Salter Labs EtCO2 sampling cannulas and gas sampling lines, non-DEHP SalterStat Capnography Product Line Salter Labs Infant Face Mask Salter Spirometer Salter Labs Humidifier 7900 Series; 7900 Series with Cannula Kit Salter Labs Peak Flow Meter PneumoTherm Salter Labs In Line Water Trap Disposable blood pressure cuff Parker Intubating Stylet, sheathed (STLT) Parker Flex-it Directional Stylet Gas Sampling Lines Kit and Gas Tubing Salter AIRE Plus® Salter NebuTech® HDN® Disposable Nebulizer Pressure Infusor Infusor, Disposable, INFUSEIT Infusor, Reusable, INFUSEIT Salter Labs nasal cannulas, 16Soft series, 16 series, high flow series, OTC series, gator and ear wraps accessory Comfort Soft Plus Salter Labs® 8900 Series Small Volume Jet Nebulizer Aspen Hybrid Sensitive Grips, Tender Grips Salter Labs Sleep Diagnostic Cannulas, non DEHP ResMed Salter Style Cannula THERAPEP DHD Healthcare Corp Aloha Nasal Aire II Bravo Luma Wrap Nasal Aire Salter Labs PEP Device Nebulizer Endotracheal Tube Curved, w/ stylet (PFRUS) Endotrachael Tube, Preformed Nasal, cuffed (PFNC) Endotrachael Tube, Preformed Nasal, uncuffed (PFNU) Parker Standard Tip Endobronchial Tube (PSTDR) Endotracheal Tube, Polyurethane, ThinCuff (PTCL) EasyCurve Endotracheal Tube, Cuffed (PFEC) Endotrachael Tube, High Volume, Low pressure, cuffed (PFST) with stylet Endotracheal Tube, Preformed, Nasal, Cuffed (PFNC) Endotracheal Tube, Reinforced, Cuffed (PFRC) Endotracheal Tube, Reinforced, uncuffed (PFRU) Endotracheal Tube, Polyurethane, ThinCuff (PTCY) Endotrachael Tube, High Volume, Low pressure, cuffed (PFHV) Micro-laryngeal Tube, Parker flex tip (PMLT) Endotracheal Tube, High Volume, Low Pressure, cuffed with Stylet (PFST) Parker Standard Tip Endobronchial Tube (PSTDL) Endotracheal Tube, Preformed Oral Cuffed Low Profile (PFOL) Parker Flex Tip Tracheal Tube, uncuffed (PFUO) Endotrachael Tube, Preformed Oral, uffed (PFOC) Endotrachael Tube, Preformed Oral, Uncuffed (PFOU) Endotrachael Tube, Low pressure, cuffed (PFLP) ENDOTRACHEAL TUBE, REINFORCED, CURVED, UN-CUFFED (PFRO) Endotracheal Tube, Reinforced, Cuffed w/ stylet (PFRCS) Endotracheal Tube, Reinforced, Cuffed (PFRP) Salter NebuTech® HDN®Reusable Nebulizer Salter Labs® Percent-O2-Lock® Venturi System Salter Labs Nebulizer exhalation filter, 8680 series Hybrid AV Grippies, Silicon Strips, MiniWhiskers, StickyWhiskers Salter Labs Bubble Humidifier Liter Meter Parker Laryngeal Mask, Disposable, Wire Reinforced Parker Laryngeal Mask, disposable, silicone Hybrid NE Hybrid HV Utopia HV Utopia NE Oxygen tubing, connectors, and accessories Salter Labs Humidifier Salter Labs Nebulizer exhalation filter, 8980 series Tilson Trach Guard and Tether Comfort Soft Plus Cannula Nasal Aire II Critical Care ACCU-FLOW Venturi Oxygen System Sticky Whiskers® Securement Device MINI WHISKERS® Securement Device Endotracheal Tube, Polyurethance, Thin cuff (PTCL) EasyCurve Endotracheal tube, articulating cord, cuffed (PFEC) Endotracheal Tube, uncuffed (PFUO) Endotracheal Tube, Endotrachael Tube, Low profile, cuffed (PFLP) Micro-laryngeal tube, Parker flex-tip (PMLT) Endotracheal Tube, High vol, low pressure (PFHV) cuffed, pre-loaded with sheathed stylet (PFST) Endotracheal Tube, Reinforced, cuffed (PFRC) Endotracheal Tube, Preformed, oral, uncuffed (PFOU) Endotrachael Tube, High Volume, Low Pressure, Cuffed (PFHV) Endotracheal Tube, Reinforced, un-cuffed (PFRU) Endotrachael tube, Preformed, Oral, cuffed (PFOC) Parker Standard Tip Endobronchial (PSTDR) Endotracheal Tube, preformed, Nasal, Uncuffed (PFNU) Endotracheal Tube, Polyurethane, Thincuff, (PTCY) Parker Standard Tip Endobronchial PSTDL Endotracheal Tube, High volume Low Pressure, cuffed (PFST) Endotracheal Tube, Preformed oral, Cuffed, low Profile (PFOL) Endotracheal Tube, preformed, Nasal, cuffed (PFNC) Parker Nasopharyngeal Airway with Parker Flex-tip CPAP Cannulaide® Capnovue VitalCheck Blood Pressure Cuff Cannula, Nasal, Oxygen, with E-Z wraps Sylent DuraCheck Blood Pressure Cuff Salter Labs Demand Cannulas

    Establishment Types

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