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Ohio Medical LLC

Last updated September 17, 2026

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 130 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	HS-12UO-DFJMC4	FDA UDI	Class I	Active
Ohio	HS-10UW-DHMMC4	FDA UDI	Class I	Active
Ohio	HS-15UA-DHDCN4	FDA UDI	Class I	Active
Ohio	HS-15UC-DMOMC4	FDA UDI	Class I	Active
Ohio	HS-10U2-OMM4C4	FDA UDI	Class I	Active
Ohio	HS-08UW-CFDFC4	FDA UDI	Class I	Active
Ohio	HS-01UN-DHDMN4	FDA UDI	Class I	Active
Ohio	HS-25UA-CFCMC4	FDA UDI	Class I	Active
Surgical Free Flow Vacuum Regulator	SCSA	FDA UDI	Class II	Active
Ohio	HS-15UN-OFOMC4	FDA UDI	Class I	Active
Ohio	HS-12UV-DHM2C4	FDA UDI	Class I	Active
Ohio	HS-08UA-PFPMN4	FDA UDI	Class I	Active
Ohio	HS-01UC-DFOMC4	FDA UDI	Class I	Active
Ohio	HS-20UW-DHXXC4	FDA UDI	Class I	Active
Ohio	HS-20UO-DHDMC4	FDA UDI	Class I	Active
Amvex Vacuum Regulator	L3L	FDA UDI	Class II	Active
Ohio	HS-06SA-NFGMC4	FDA UDI	Class I	Active
Ohio	HS-12UW-DHDMC4	FDA UDI	Class I	Active
Ohio	HS-10UC-DHOFN4	FDA UDI	Class I	Active
Ohio	HS-04UW-DFDFN5	FDA UDI	Class I	Active
Ohio	HS-20U2-DFDCC4	FDA UDI	Class I	Active
Ohio	GR-540-FM15-PT	FDA UDI	Class I	Active
Ohio	HS-25UA-CMM2C4	FDA UDI	Class I	Active
Ohio	HS-06UV-DFMFN4	FDA UDI	Class I	Active
Ohio	HS-15UO-DHDHC4M	FDA UDI	Class I	Active
Ohio	HS-15UA-SFOMC4	FDA UDI	Class I	Active
Ohio	GR-890-FM16	FDA UDI	Class I	Active
Ohio	HS-10U2-CFCMC4	FDA UDI	Class I	Active
Ohio	HS-08UH-DHDHC4	FDA UDI	Class I	Active
Ohio	HS-40UV-DHPMC4	FDA UDI	Class I	Active
Ohio	HS-25UN-F2F4C4	FDA UDI	Class I	Active
Ohio	HS-17UC-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-06UA-DFCMC4M	FDA UDI	Class I	Active
Amvex Vacuum Regulator	NIA	FDA UDI	Class II	Active
Ohio	HS-10UO-DFDHC4	FDA UDI	Class I	Active
Ohio	HS-10UA-DHPMN4M	FDA UDI	Class I	Active
Ohio	HS-03UV-DADFC5	FDA UDI	Class I	Active
Ohio	HS-40UC-DFOMC4	FDA UDI	Class I	Active
Ohio	HS-30UO-DHDHN4	FDA UDI	Class I	Active
Ohio	HS-10UV-M2OMC5	FDA UDI	Class I	Active
Ohio	HS-03U2-DHPFC4	FDA UDI	Class I	Active
Ohio	HS-01UO-DHM2N4	FDA UDI	Class I	Active
Ohio	HS-01UN-DCSMC4	FDA UDI	Class I	Active
Amvex Vacuum Regulator	CHN	FDA UDI	Class II	Active
Ohio	HS-10UO-DHDMC4	FDA UDI	Class I	Active
Ohio	HS-01UW-DFDFC5	FDA UDI	Class I	Active
Ohio Medical Vacuum Regulator	PILA	FDA UDI	Class II	Unknown
Ohio	HS-40U2-DFCMC4	FDA UDI	Class I	Active
Ohio	HS-03UV-DFXXC5	FDA UDI	Class I	Active
Ohio	HS-15UA-DFOMN4	FDA UDI	Class I	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.