BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Katmai Health Services LLC

    Reg #: 3012104670 · FEI: 3012104670 · Expires 2026
    View on FDA
    Products
    61
    Proprietary Names
    67
    Establishment Types
    2
    Classifications
    61

    Registration Details

    Registration Name
    Katmai Health Services LLC
    Registration Number
    3012104670
    FEI Number
    3012104670
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    34 Kelley Way
    City
    Brilliant
    State
    OH
    ZIP
    43913
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN060009

    Owner / Operator

    Firm Name
    Katmai Health Services, LLC
    Operator Number
    10050389
    Address
    701 E. Tudor Rd., Suite 215
    City
    Anchorage
    State
    AK
    Postal Code
    99503
    Country
    US

    Products

    Device Name Product Code
    Respirator, N95, For Use By The General Public In Public Health Medical Emergencies NZJ
    Syringe, Piston FMF
    Ophthalmoscope, Battery-Powered HLJ
    Bedpan FOB
    Mask, Surgical FXX
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Stethoscope, Manual LDE
    Container, Sharps MMK
    Catheters, Suction, Tracheobronchial BSY
    Latex Patient Examination Glove LYY
    Tape And Bandage, Adhesive KGX
    Set, Administration, Intravascular FPA
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Gauze / Sponge,Nonresorbable For External Use NAB
    Gown, Examination FME
    Needle, Hypodermic, Single Lumen FMI
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW
    Polymer Patient Examination Glove LZA
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD
    Computer, Blood-Pressure DSK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter DQA
    Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO
    Tube, Tracheostomy (W/Wo Connector) BTO
    Automated External Defibrillators (Non-Wearable) MKJ
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Mask, Oxygen, Non-Rebreathing KGB
    Depressor, Tongue, Non-Surgical FMA
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Hemostat, Surgical EMD
    Continuous Measurement Thermometer FLL
    Medical Glove, Specialty LZC
    Lubricant, Patient KMJ
    Glucose Oxidase, Glucose CGA
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Hospital Cardiac Telemetry QYW
    Laryngoscope, Rigid CCW
    Tube, Tracheal (W/Wo Connector) BTR
    Bandage, Elastic FQM
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Stretcher, Hand-Carried FPP
    Airway, Oropharyngeal, Anesthesiology CAE
    Catheter, Cholangiography GBZ
    Blood Pressure Cuff DXQ
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Electrode, Ion Specific, Sodium JGS
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Airway, Nasopharyngeal BTQ
    Body Fluids Barrier Kit OKH
    First Aid Kit Without Drug OHO
    Catheter, Retention Type, Balloon EZL
    Surgeon'S Gloves KGO
    First Aid Kit With Drug LRR

    Proprietary Names

    EXEL 10-12CC SYRINGE ONLY LUER-LOCK W/CAP Syringe, Luer Lock Tip, w/22 GA x 1" Needle, 3mL EXEL HYPODERMIC SYRINGE NEEDLES / EXEL HYPODERMIC NEEDLE 25GA X 1 1/2" - 100/BX EXEL HYPODERMIC SYRINGE NEEDLES / HYPODERMIC NEEDLE 18GA X 1" - 100/BX EXEL SYRINGE ONLY 20-25CC LUER LOCK / EXEL 20-25CC SYRINGE ONLY LUER-LOCK W/CAP-50/BX EXEL SYRINGE ONLY 30-35CC LUER LOCK / EXEL 30-35CC SYRINGE ONLY LUER-LOCK W/CAP-50/BX EXEL HYPODERMIC SYRINGE NEEDLES / HYPODERMIC NEEDLE 20GA X 1.5" - 100/BX BEDPAN FRACTURE 6S Blood Pressure Cuff, Large MEDSTORM ADULT BLOOD PRESSURE CUFF Blood Pressure Cuff, Adult IV ADMIN SET 10DROPS/ML Disposable Gown Patient EXEL I.V. ADMINISTRATION SET / EXEL STANDARD I.V. SET, 15 DROPS/ML, 78" LONG-50/CS Hypodermic Needle, Safety, Pink, 18GA x 1 1/2" Hypodermic Needle, Safety, Orange, 25GA x 1 1/2" Hypodermic Needle, Safety, Yellow, 20GA x 1 1/2" N/S Mask. Oronasal, Adult, Disposable Hypodermic Needle, Safety, Black, 22GA x 1 1/2" Syringe, Luer Lock Tip, w/o Needle, 10cc Syringe, Luer Lock Tip, w/o Needle, 60cc EZ IO 45MM 15GA SET EZ-IO Needle Sets EZ IO DRIVER EZ-IO N/S intraossoeus infusion kit 15Ga x 15 MM Pediatric ZOLL PROPAQ MD PERTRACH 5MM Hypodermic Needle, Black, 22GA x 1" Hypodermic Needle, Pink, 18GA x 1.5" NAR NEEDLELESS SALINE LOCK KIT NAR SALINE LOCK KIT ADC DIAGNOSTIX™ 700 SERIES / ADC DIAGNOSTIX 700 SERIES BP CUFF, BLACK, ADULT, LATEX FREE TONGUE DEPRESSORS, STERILE, 6" BAG,URINE COLLECTION 2 Liters URINARY LEG BAG, LG 1000ML, TWIST VALVE, ST FORCEPS HEMOSTATIC CO2 DETECTOR, ADULT MALLINCKRODT EASY-CAP II / PEDI-CAP II / NELLCOR EASY CAP II END TIDAL CO2 DETECTOR, ADULT 2 SEPARATE PARTS ADTEMP II 413 DIGITAL THERMOMETERS AND COVERS / ADC ADTEMP DIGITAL THERMOMETER SHEATHS ADTEMP™ 419 HYPOTHERMIA THERMOMETERS / ADC ADTEMP DIGITAL HYPOTHERMIA THERMOMETER LIFESCAN ONETOUCH ULTRA TEST STRIPS / ONE TOUCH ULTRA BLUE TEST STRIPS INTRAOSSEOUS INFUSION SYSTEM WELCH ALLYN FIBER OPTIC LARYNGOSCOPE BLADES / WELCH-ALLYN FIBER OPTIC MAC 3 LARYNGOSCOPE BLADE WELCH ALLYN FIBER OPTIC LARYNGOSCOPE BLADES / WELCH-ALLYN FIBER OPTIC MAC 4 LARYNGOSCOPE BLADE WELCH ALLYN FIBER OPTIC LARYNGOSCOPE HANDLES / WELCH-ALLYN FIBER OPTIC LARYNGOSCOPE HANDLE Wrap, Self-Adherent, 4" x 5 yds, Latex Free, Sterile, Tan ELASTIC BANDAGES / 4" X 5 YD ELASTIC BANDAGE W/VELCRO CLOSURE ELASTIC BANDAGES / 6" X 5 YD ELASTIC BANDAGE W/VELCRO CLOSURE Bandage, Elastic, Latex Free LATEX FREE BANDAGE ADHESIVE TAPE, COMBAT MEDIC, REINFORCED, 2" x 100" OXIMETER,PULSE EVAC POLELESS LITTER AIRWAY KIT, SUPRAGLOTTIC, Size 5 AIRWAY KIT, ORAL, Six Piece Set GLIDESCOPE TITANIUM SINGLE USE Sphygmomanometer, MediChoice Adult Economy Latex-Free (BRAND NOT AVAILABLE) AIRWAY KIT, SUPRAGLOTTIC, Size 4 HOSPIRA STANDARD IV SET W/OPT LOCK15 DRPS/ML 100", NON- Syringe, Slip Tip, w/o Needle, 10cc Syringe, Disposable, Luer Lock Tip, w/o Needle, 3cc Syringe, Disposable, Safety Luer Lock Tip, w/o Needle, 10cc Syringe, Disposable, Luer Lock Tip, w/o Needle, 60cc Syringe, Disposable, Luer Lock Tip, w/o Needle, 10cc Syringe, Safety Luer Lock Tip, w/25 GA x 5/8" Needle, 1mL CATHETER URET 18FR 12s I.V. Administartion Set, 10-15-60 Drop

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device