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Ohio Medical LLC

Last updated September 17, 2026

What Ohio Medical LLC makes

Ohio Medical LLC manufactures reusable general-gas low pressure tubing, non-fixed medical gas cylinder regulators, vacuum suction regulators and regulation sets for general-purpose use, Thorpe tube medical gas flowmeters, oxygen and carbon dioxide low pressure hoses, and reusable surgical suction system collection containers, along with vacuum hoses.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's Unique Device Identification (fda_udi) registry. Ohio Medical LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Ohio Medical LLC make?

Where is Ohio Medical LLC based?

Ohio Medical LLC is based in the United States.

Which registries list Ohio Medical LLC's devices?

Ohio Medical LLC's devices are listed in the FDA's Unique Device Identification (fda_udi) registry.

How are Ohio Medical LLC's devices classified?

Ohio Medical LLC's devices are classified as Class I and Class II medical devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 1111 LAKESIDE DR, Gurnee, IL, 60031
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1419185
DUNS Number: —

Catalogue (6983)

Page 83 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	HS-04UA-DFM4C4	FDA UDI	Class I	Active
Ohio Medical Vacuum Regulator	LC2SA	FDA UDI	Class II	Unknown
Ohio	HS-20U2-F4F4C4	FDA UDI	Class I	Active
Amvex Vacuum Regulator	LPB	FDA UDI	Class II	Active
Ohio	FI-T15UO-DN-F	FDA UDI	Class I	Active
Ohio	HS-04UO-DFPFN4	FDA UDI	Class I	Active
Ohio	HS-03UA-DHDHN4	FDA UDI	Class I	Active
Ohio	HS-99UO-F4F4C4	FDA UDI	Class I	Active
Ohio	HS-CS-EV-02002	FDA UDI	Class I	Active
Ohio	HS-02U2-F4F4C4	FDA UDI	Class I	Active
Ohio	HS-CS-NC-02022	FDA UDI	Class I	Active
Ohio	HS-17U2-DFDFN4	FDA UDI	Class I	Active
Ohio	HS-25UO-OFDMC4	FDA UDI	Class I	Active
Tote-L-Vac	Tote-L-Vac	FDA UDI	Class II	Active
Ohio	HS-10U2-OFXXC4	FDA UDI	Class I	Active
Ohio	HS-08U2-DFDFN4	FDA UDI	Class I	Active
Amvex Vacuum Regulator	PIL	FDA UDI	Class II	Active
Ohio	HS-10UO-F4DMC4	FDA UDI	Class I	Active
Ohio	HS-08UW-DFDMN5	FDA UDI	Class I	Active
Ohio	HS-40UV-DHCMC5	FDA UDI	Class I	Active
Ohio	HS-25U2-DHXXC4	FDA UDI	Class I	Active
Ohio	GR-280-FM16-SWN	FDA UDI	Class I	Active
Ohio	HS-04UN-DFF2N4	FDA UDI	Class I	Active
Ohio	HS-15U2-DHDHC4	FDA UDI	Class I	Active
Ohio	GR-540-FM15-XXI	FDA UDI	Class I	Active
Ohio	HS-04UN-F4F4C4	FDA UDI	Class I	Active
Ohio	HS-18UO-CMM4C4	FDA UDI	Class I	Active
Ohio	HS-03UV-DFDCC4	FDA UDI	Class I	Active
Ohio	HS-50UO-CMXXC4	FDA UDI	Class I	Active
Ohio	HS-03UW-DHXXC4	FDA UDI	Class I	Active
Flowmeter Dial	FM-D-15IA	FDA UDI	Class I	Active
Amvex Vacuum Regulator	L2B	FDA UDI	Class II	Active
Ohio	GR-540-FM15	FDA UDI	Class I	Active
Ohio	HS-03UV-DFCEC4	FDA UDI	Class I	Active
Amvex Vacuum Regulator	N2B	FDA UDI	Class II	Active
Ohio	HS-23UA-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-10UA-DFF6C4	FDA UDI	Class I	Active
Ohio	HS-18UV-DHDHC5	FDA UDI	Class I	Active
Ohio	HS-04UO-DMOMC4	FDA UDI	Class I	Active
Ohio	HS-04UO-CFDHC4	FDA UDI	Class I	Active
Ohio	HS-05UN-DHM2C4	FDA UDI	Class I	Active
Ohio	HS-30UV-DCOMC5	FDA UDI	Class I	Active
Ohio	HS-16UN-F2F2C4	FDA UDI	Class I	Active
Ohio	HS-16UW-DFOFC4	FDA UDI	Class I	Active
Amvex Vacuum Regulator	PPL	FDA UDI	Class II	Active
Ohio	HS-12UA-DFXXC4	FDA UDI	Class I	Active
Ohio	HS-01UA-DHOFC4	FDA UDI	Class I	Active
Ohio	HS-14UA-DFCMC4	FDA UDI	Class I	Active
Ohio	GR-BNO-FM15-XXN	FDA UDI	Class I	Active
Ohio	HS-30UA-DFPFC4	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Ohio Medical LLC has 9 recall records initiated between 2009-09-21 and 2025-05-08, with statuses recorded as open, classified, and terminated. The reasons given include reusable collection bottles made with incorrect material, reports of explosive events, premature device failures, battery terminal issues, erroneous calibration values, circuit board failures, and incomplete quality control testing.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 8, 2025	Z-1980-2025	—	open, classified	Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
Nov 16, 2021	Z-0482-2022	—	open, classified	Increase in premature device failures
Aug 14, 2018	Z-2995-2018	—	terminated	The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.
Mar 12, 2018	Z-2410-2018	—	terminated	Final quality control testing was not completed before the devices were distributed..
Nov 8, 2010	Z-0833-2011	—	terminated	The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.
May 10, 2010	Z-1777-2010	—	terminated	Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.
May 10, 2010	Z-1778-2010	—	terminated	Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.
Sep 21, 2009	Z-0089-2010	—	terminated	The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
Sep 21, 2009	Z-0090-2010	—	terminated	The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.