BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KATMAI INTEGRATED SOLUTIONS

    Reg #: 3015997711 · FEI: 3015997711 · Expires 2026
    View on FDA
    Products
    61
    Proprietary Names
    67
    Establishment Types
    1
    Classifications
    61

    Registration Details

    Registration Name
    KATMAI INTEGRATED SOLUTIONS
    Registration Number
    3015997711
    FEI Number
    3015997711
    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
    K945806

    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
    Correspondent
    Lisa Talkington

    Products

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

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device