Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015997711

FEI Number

3015997711

Entity Name

KATMAI INTEGRATED SOLUTIONS

City/State/Country

Brilliant, OH, US

Establishment Address

34 Kelley Way, Brilliant, OH 43913, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Katmai Health Services, LLC (Owner Number: 10050389)

Owner / Operator Contact Address

701 E. Tudor Rd., Suite 215, Anchorage, AK 99503, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082362

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2016-04-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2016-12-15
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2016-12-15
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2016-04-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-04-08
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2016-12-15
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-12-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-04-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-12-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-04-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-04-08
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2016-12-15
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2015-11-12
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-04-08
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2016-12-15
QYW	Hospital Cardiac Telemetry	Cardiovascular	Class 2	870.1025	2016-12-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-04-08
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2015-11-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-04-08
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2016-12-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-04-08
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2016-04-08
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2016-04-08
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2016-04-08
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2016-04-08
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2016-04-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-04-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-04-08
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	Class 2	870.5550	2016-04-08
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-12-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-04-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-12-15
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-04-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2016-12-15
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2015-11-12
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2015-11-12
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2016-12-15
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2016-12-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-04-08
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2016-12-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-04-08
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2016-12-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2016-04-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-04-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-04-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-12-15
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2016-04-08
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2016-04-08
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-04-08
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2015-11-12
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2015-11-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-04-08
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
OKH	Body Fluids Barrier Kit	General, Plastic Surgery	Class 2	878.4040	2015-11-12
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2015-11-12
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2015-11-11
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-04-08
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2016-12-15
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-12-15
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-12-15
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2016-04-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-04-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-04-08

Official Correspondent

Lisa Talkington

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Katmai Health Services, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012104670	Katmai Health Services LLC	Brilliant, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04
K801007	Instrumentation Laboratory CO	IL SYSTEM 502 NA/K ANALYZER	1980-05-14
K760969	Instrumentation Laboratory CO	PH/BLOOD GAS SYSTEM	1977-01-12
K820744	Instrumentation Laboratory CO	IL MODEL 1301, PH BLOOD GAS SYSTEM	1982-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer
Z-0845-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Z-0846-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015997711. Last updated year: 2026. Please use registration number 3015997711 when referencing this establishment in official correspondence.