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Ohio Medical LLC

US

Last updated September 17, 2026

Information

Country
US
Address
1111 LAKESIDE DR, Gurnee, IL, 60031
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
1419185
DUNS Number
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Catalogue (6983)

Page 115 of 140
DeviceModel / ReferenceRegistriesClassStatus
Ohio HS-04UA-DFOFC4
FDA UDI
Class IActive
Ohio Medical Vacuum Regulator LC2LA
FDA UDI
Class IIActive
Ohio HS-04UW-F2OFC4
FDA UDI
Class IActive
Ohio HS-20UO-DFF2C4
FDA UDI
Class IActive
Ohio HS-14UV-F4XXC4
FDA UDI
Class IActive
Ohio HS-20UN-DMM2C4
FDA UDI
Class IActive
Ohio HS-20UW-DFPFC4
FDA UDI
Class IActive
Ohio HS-20UC-DMOMC4
FDA UDI
Class IActive
Ohio HS-12UV-DHCMC4
FDA UDI
Class IActive
Ohio HS-12UC-DFM2C4
FDA UDI
Class IActive
Ohio HS-04UV-DFDFC4
FDA UDI
Class IActive
Ohio HS-14UN-DFXXC4
FDA UDI
Class IActive
Ohio HS-04U2-DFOMC4
FDA UDI
Class IActive
Ohio HS-15UC-DFDEC4
FDA UDI
Class IActive
Ohio HS-01U2-DHOFC4
FDA UDI
Class IActive
Ohio GR-346-FM15-PT
FDA UDI
Class IActive
Ohio HS-12UW-DFPMC4
FDA UDI
Class IActive
Ohio HS-12UC-CFDFC4
FDA UDI
Class IActive
Ohio HS-10UC-DFOMC4
FDA UDI
Class IActive
Ohio HS-08UO-CFDFC4
FDA UDI
Class IActive
Ohio HS-01UO-DFOMC4
FDA UDI
Class IActive
Ohio HS-25UV-CFOMC4
FDA UDI
Class IActive
Ohio HS-04UW-DHDCC4
FDA UDI
Class IActive
Ohio HS-03UV-OMOMC5
FDA UDI
Class IActive
Ohio HS-15UO-DFDEC4
FDA UDI
Class IActive
Ohio HS-04UW-DFCMC4
FDA UDI
Class IActive
Ohio HS-04UV-DFCMC4
FDA UDI
Class IActive
Ohio HS-01UC-DHF4N4
FDA UDI
Class IActive
Ohio HS-08UA-DFCMN4
FDA UDI
Class IActive
Ohio GR-910-OF
FDA UDI
Class IActive
Ohio HS-22UN-DFSMC4
FDA UDI
Class IActive
Ohio HS-10UV-DFPFC5
FDA UDI
Class IActive
Ohio HS-03UN-F2M4C4
FDA UDI
Class IActive
Ohio HS-03UV-DFOFN4
FDA UDI
Class IActive
Ohio GR-346-FM15
FDA UDI
Class IActive
Ohio HS-15U2-SFOMC4
FDA UDI
Class IActive
Ohio HS-30UW-DHXXN5
FDA UDI
Class IActive
Ohio HS-01U2-OMM4C4
FDA UDI
Class IActive
Ohio HS-19UN-DFM4C4
FDA UDI
Class IActive
Ohio HS-15UO-DFDFC4B
FDA UDI
Class IActive
Ohio HS-20UW-DHDHC4
FDA UDI
Class IActive
Ohio HS-03UV-DMM6C5
FDA UDI
Class IActive
Ohio HS-08UA-DHOMC4
FDA UDI
Class IActive
Ohio HS-03UO-CFDFC4
FDA UDI
Class IActive
Ohio HS-01UA-DFM6C4
FDA UDI
Class IActive
Ohio HS-09UO-DFOMC4
FDA UDI
Class IActive
Ohio HS-12UO-DMPMC4
FDA UDI
Class IActive
Ohio HS-01UO-CFDHC4
FDA UDI
Class IActive
Ohio HS-03UC-DHM4N4
FDA UDI
Class IActive
Ohio HS-01UO-OFDFN4
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.

DateRecall No.ClassStatusReason
May 8, 2025Z-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, 2021Z-0482-2022—open, classified

Increase in premature device failures

Aug 14, 2018Z-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, 2018Z-2410-2018—terminated

Final quality control testing was not completed before the devices were distributed..

Nov 8, 2010Z-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, 2010Z-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, 2010Z-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, 2009Z-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, 2009Z-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.