FDA.reportPublic FDA data

Ohio Medical Vacuum Regulator

Primary DI
08688250002115
Brand
Ohio Medical Vacuum Regulator
Company
OHIO MEDICAL, LLC
Model
PC2HA
Device description
Vacuum Regulator, Push to Set, Continuous 2Mode, 760mmHg Analog
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDPRegulator, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08688250002115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08688250002115086882500021158688250002115

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, general-purposeA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18478550500customer.service@ohiomedical.com

Regulatory Flags#

DUNS number
005192885
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628101620387OhioGR-CS-PA-01001GR-CS-PA-010012026-05-18
00628101620837OhioGR-CS-AS-01001GR-CS-AS-010012026-05-18
00628101620851OhioGR-MU-00101GR-MU-001012026-05-18
00628101632618OhioAM-TH300440AM-TH3004402026-05-18
00628101632625OhioGR-F4OGR-F4O2026-05-18
00628101632496Ohio HS-13IV-DFXXC4 HS-13IV-DFXXC42026-05-13
00628101632502OhioHS-13U2-DFXXC4HS-13U2-DFXXC42026-05-13
00628101632557Ohio HS-01UW-CFCMC4 HS-01UW-CFCMC42026-05-13
00628101632472OhioHS-15UV-F2CMC4HS-15UV-F2CMC42026-05-06
00628101632519OhioHS-20UO-DEOEC4HS-20UO-DEOEC42026-05-06
00628101632526Ohio HS-20UA-DAOEC4 HS-20UA-DAOEC42026-05-06
00628101632540OhioHS-25UI-DFXXC4HS-25UI-DFXXC42026-05-06
00628101632434Ohio HS-30U2-CFDFC4 HS-30U2-CFDFC42026-05-05
00628101632441Ohio HS-30UW-CFDFC5 HS-30UW-CFDFC52026-05-05
00628101632533OhioHS-CS-RM-02002HS-CS-RM-020022026-05-05
00628101632489Ohio HS-25UC-DFF4C4 HS-25UC-DFF4C42026-04-17
00628101608187OhioFI-T01UO-DN-EFI-T01UO-DN-E2026-04-15
00628101608194OhioFI-T01UO-ON-EFI-T01UO-ON-E2026-04-15
00628101608200OhioFI-T03UO-CN-BFI-T03UO-CN-B2026-04-15
00628101608217OhioFI-T03UO-CN-EFI-T03UO-CN-E2026-04-15

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Primary DI, Brand, Company table
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