Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012104670

FEI Number

3012104670

Entity Name

Katmai Health Services LLC

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

K940918

PMA Number

N/A

All Registered 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, 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NZJ	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies	General Hospital	Class 2	880.6260	2016-12-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-04-08
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2016-12-15
FOB	Bedpan	General Hospital	Class 1	880.6730	2016-04-08
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2016-12-15
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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-04-08
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2015-11-12
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2016-12-15
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2015-11-12
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-12-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-04-08
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2015-11-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-12-15
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-12-15
FME	Gown, Examination	General Hospital	Class 1	880.6265	2016-04-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-04-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-04-08
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2016-04-08
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
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-04-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-04-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
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
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2015-11-12
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	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
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2016-12-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-04-08
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-04-08
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2016-04-08
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2016-04-08
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2016-04-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-12-15
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2016-04-08
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2015-11-12
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2016-04-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	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
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2016-12-15
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-04-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-04-08
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
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2016-04-08
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2016-12-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-04-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-12-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-12-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-12-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-04-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-15
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2016-04-08
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-04-08
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-04-08
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2016-04-08
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2016-12-15
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2016-04-08
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2015-11-12
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-04-08
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2015-11-12
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

Official Correspondent

No official correspondent registered.

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
3015997711	KATMAI INTEGRATED SOLUTIONS	Brilliant, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012104670. Last updated year: 2026. Please use registration number 3012104670 when referencing this establishment in official correspondence.