Is this your brand? Sign in to claim ownership.

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 6 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	B3	FDA UDI	Class II	Active
Ohio	HS-15UO-CMXXN4	FDA UDI	Class I	Active
Ohio	HS-10UA-BMBMC4	FDA UDI	Class I	Active
Ohio	GR-326	FDA UDI	Class I	Active
Ohio	HS-25UV-DFDFC4M	FDA UDI	Class I	Active
Ohio	HS-08UV-CFCMC4	FDA UDI	Class I	Active
Ohio	HS-16U2-DHCMC4	FDA UDI	Class I	Active
Ohio	HS-20UV-DMOMC5	FDA UDI	Class I	Active
Ohio	HS-14UO-CMDMC4	FDA UDI	Class I	Active
Ohio	HS-12UV-OMXXC4	FDA UDI	Class I	Active
Ohio	HS-10UW-DFF2C4	FDA UDI	Class I	Active
Ohio	GR-950-E9XX-SF8	FDA UDI	Class I	Active
Ohio	HS-12UW-PFPMC4	FDA UDI	Class I	Active
Ohio	HS-12UA-CMDCC4	FDA UDI	Class I	Active
Ohio	HS-01UA-DCCFC4	FDA UDI	Class I	Active
Ohio	HS-01UC-DHM4C4	FDA UDI	Class I	Active
Ohio	HS-35UO-CFF4C4	FDA UDI	Class I	Active
Ohio	HS-18U2-DFXXC4	FDA UDI	Class I	Active
Ohio	HS-14UA-DFDMC4	FDA UDI	Class I	Active
Ohio	HS-10UW-M4OMC4	FDA UDI	Class I	Active
Ohio	HS-35UW-DFCEC4	FDA UDI	Class I	Active
Ohio	HS-15UA-DFPMC4M	FDA UDI	Class I	Active
Ohio	HS-03UO-OFPMC4	FDA UDI	Class I	Active
Ohio	HS-33UA-OFOMC4	FDA UDI	Class I	Active
Ohio	HS-03UO-DHOFC4	FDA UDI	Class I	Active
Ohio	GR-870-BFXX-XXI	FDA UDI	Class I	Active
Ohio	HS-CS-ZM-02003	FDA UDI	Class I	Active
Ohio	HS-04UW-DFOMC4	FDA UDI	Class I	Active
Ohio	HS-08UN-DFF2C4	FDA UDI	Class I	Active
Ohio	HS-03U2-DHOFC4	FDA UDI	Class I	Active
Ohio	HS-20UO-DHHEN4	FDA UDI	Class I	Active
Ohio	HS-CS-EC-02001	FDA UDI	Class I	Active
Ohio	HS-12UA-DHDCC4	FDA UDI	Class I	Active
Ohio	HS-08UA-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-04UO-DFDFN4	FDA UDI	Class I	Active
Ohio	HS-12UV-DMXMC4	FDA UDI	Class I	Active
Amvex Vacuum Regulator	N2N	FDA UDI	Class II	Active
Ohio	GR-346-CF	FDA UDI	Class I	Active
Ohio	HS-04UN-DFSFN4	FDA UDI	Class I	Active
Ohio	HS-18UN-DFXXC4	FDA UDI	Class I	Active
Ohio	HS-24UO-OFOMC4	FDA UDI	Class I	Active
Ohio	HS-18UN-DHM2N4	FDA UDI	Class I	Active
Ohio	HS-12UV-DFCMC5	FDA UDI	Class I	Active
Ohio	HS-10UA-DFMMC4	FDA UDI	Class I	Active
Ohio	HS-CS-HE-02001	FDA UDI	Class I	Active
Ohio	HS-03UV-CFOMN4	FDA UDI	Class I	Active
Amvex Vacuum Regulator	PPP	FDA UDI	Class II	Active
Ohio	HS-20UO-DFDMC4	FDA UDI	Class I	Active
Ohio	HS-20UV-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-16UV-OMXXC5	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.

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.