FDA.reportPublic FDA data

Ohio

Primary DI
00628101612863
Brand
Ohio
Company
OHIO MEDICAL, LLC
Model
V1
Catalog number
6700-0270-700
Device description
Venturi
Published
2021-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00628101612863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101612863006281016128636281016128630628101612863

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic suction regulator/regulation setA noninvasive device/collection of noninvasive devices designed to convert positive gas pressure from a compressed gas supply, into negative pressure (the Venturi principle) for the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). The device is designed to be connected to the gas supply (e.g., air, oxygen cannister) to achieve controlled continuous and/or intermittent suction at variable levels. It includes a manometer, an activation knob, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)855-6218customer.service@ohiomedical.com

Regulatory Flags#

DUNS number
005192885
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344148332MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-04
10197344148707MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-04
08435510650872TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510655150TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679033TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679064TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679071TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679088TITANIUM VAC REGHERSILL SLKDP2026-08-25
10197344144181MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-08-07
10197344144693MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144709MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144716MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144723MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144730MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144747MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144754MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144761MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144778MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144785MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144792MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144808MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144815MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144822MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146161MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146178MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146185MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146192MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146208MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146215MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146222MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24