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Ohio Medical LLC

Last updated September 17, 2026

Information

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

Catalogue (6983)

Page 140 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	HS-01UN-M4F2N4	FDA UDI	Class I	Active
Flowmeter, Thorpe	FM-OT-01IO	FDA UDI	Class I	Active
Ohio	GR-540-DCXX-XXH	FDA UDI	Class I	Active
Amvex Vacuum Regulator	C2H	FDA UDI	Class II	Active
Amvex Vacuum Regulator	NIB	FDA UDI	Class II	Active
Amvex Vacuum Regulator	NNL	FDA UDI	Class II	Active
Flowmeter, Thorpe	FM-OT-15NO	FDA UDI	Class I	Active
Amvex Vacuum Regulator	PIA	FDA UDI	Class II	Active
Moblvac III	Moblvac III-CS	FDA UDI	Class II	Unknown
Amvex Vacuum Regulator	LCA	FDA UDI	Class II	Active
Flowmeter, Thorpe	FM-T-15UA	FDA UDI	Class I	Active
MiniOX	MINIOX 3000S	FDA UDI	Class II	Unknown
Amvex Vacuum Regulator	L2H	FDA UDI	Class II	Active
Flowmeter Dial	FM-D-08UA	FDA UDI	Class I	Active
Flowmeter, Thorpe	FM-T-15UO	FDA UDI	Class I	Active
Amvex Vacuum Regulator	PIN	FDA UDI	Class II	Active
Amvex Vacuum Regulator	LPL	FDA UDI	Class II	Active
Flowmeter, Thorpe	FM-OT-70IA	FDA UDI	Class I	Active
Amvex Vacuum Regulator	NIP	FDA UDI	Class II	Active
Legacy Flowmeter	FM-LT15SO	FDA UDI	Class I	Active
Legacy Flowmeter	FM-LT03NO	FDA UDI	Class I	Active
Sure-Trap	70365	FDA UDI	Class II	Unknown
Flowmeter, Thorpe	FM-OT-12U2	FDA UDI	Class I	Active
Amvex Vacuum Regulator	P2N	FDA UDI	Class II	Active
Amvex Vacuum Regulator	I2N	FDA UDI	Class II	Active
Flowmeter, Thorpe	FM-T-70UO	FDA UDI	Class I	Active
MiniOX	MINIOX 3000	FDA UDI	Class II	Unknown
Amvex Vacuum Regulator	CHL	FDA UDI	Class II	Active
Amvex Vacuum Regulator	LPA	FDA UDI	Class II	Active
Amvex Vacuum Regulator	C3D	FDA UDI	Class II	Active
Flowmeter. Thorpe	FM-OT-2CUC	FDA UDI	Class I	Active
Moblvac W.c.	K081185	FDA 510(k)	Class II	Active
Care-E-Vac 3	K062610	FDA 510(k)FDA UDI	Class II	Active

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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.

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.