FDA.reportPublic FDA data

Amvex Vacuum Regulator

Primary DI
00628101501778
Brand
Amvex Vacuum Regulator
Company
OHIO MEDICAL, LLC
Model
NNP
Device description
VR-NN series, VacReg, Neo Int 2Mode 100mmHg, Analog (kPa)
Published
2016-09-24
Public version status
Update
Distribution status
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
00628101501778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101501778006281015017786281015017780628101501778

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
19057647736customerservice.ca@ohiomedical.com

Regulatory Flags#

DUNS number
005192885
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
10197344142460MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142477MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142484MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142491MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142507MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142514MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142521MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143306MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143313MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143320MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143337MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143344MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143351MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143368MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143726MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143733MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143740MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143764MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143771MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144433MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144440MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144457MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144464MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144471MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144488MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144495MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144549MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146284MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146291MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146307MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09