Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1419185

FEI Number

1419185

Entity Name

Ohio Medical LLC

City/State/Country

Gurnee, IL, US

Establishment Address

1111 LAKESIDE DR, Gurnee, IL 60031, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OHIO MEDICAL LLC (Owner Number: 1419185)

Owner / Operator Contact Address

1111 LAKESIDE DR., --, Gurnee, IL 60031, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Instavac C Moblvac III Instavac I Ohio Medical Oxygen Humidifier Suction Tubing Reusable COLLECTION BOTTLES Disposable Collection Bottles Filter and Tubing Zen-O, Zen-O Lite Oxygen Concentrator Models M50 Amvex Dial Flowmeter Tote-L-Vac CARE-E-VAC 3 Integrated Flowmeter Ohio Medical Flowmeter Amvex Flowmeter Pump Portable, Aspiration Ohio Medical DurO2 Amvex Medical Gas Regulators Amvex Compact Gas Regulators Ohio Medical Gas Regulators Vacuum Traps Amvex Vacuum Regulators Overflow Safety Traps Ohio Medical Vacuum Regulators

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2008-07-11
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2018-04-06
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	1992-08-03
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-11-22
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2024-05-28
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Anesthesiology	Class 1	868.2300	2009-03-10
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2008-07-11
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2008-03-14
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	1992-08-03
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2025-03-12
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2009-03-10
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	1992-08-03

Official Correspondent

Jessica Barrile

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OHIO MEDICAL LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1419185. Last updated year: 2026. Please use registration number 1419185 when referencing this establishment in official correspondence.