FDA.report

Amvex Vacuum Regulator

Primary DI
00628101501099
Brand
Amvex Vacuum Regulator
Company
OHIO MEDICAL, LLC
Model
C2B
Device description
VR-C2 series, VacReg, Cont 2Mode 300mmHg, Analog (mBar)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KDPRegulator, Vacuum

Product Code Classifications

CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00628101501099PrimaryGS10

GMDN Terms

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

Contacts

PhoneEmail
19057647736customerservice.ca@ohiomedical.com

Regulatory Flags

DUNS number
005192885
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00628101548254OhioHS-10IA-DFDMC4HS-10IA-DFDMC42026-03-24
00628101559618OhioHS-12IA-DHOMC4HS-12IA-DHOMC42026-03-24
00628101595708OhioHS-36U2-DHDCC4HS-36U2-DHDCC42026-03-24
00628101599980OhioHS-CS-GE-02026HS-CS-GE-020262026-03-24
00628101622374OhioHS-14UN-SFSSC4HS-14UN-SFSSC42026-03-24
00628101631543OhioHS-04UI-DHDMC4HS-04UI-DHDMC42026-03-24
00628101631567OhioHS-12UW-F4CMN5HS-12UW-F4CMN52026-03-24
00628101631574OhioHS-22IA-DFDFC4HS-22IA-DFDFC42026-03-24
00628101631628OhioHS-40UN-DFM4N4HS-40UN-DFM4N42026-03-24
00628101631635OhioHS-21IA-DBDFC4HS-21IA-DBDFC42026-03-24
00628101631642OhioHS-03IA-DHOFC4HS-03IA-DHOFC42026-03-24
00628101631673OhioHS-20UV-CADHN4HS-20UV-CADHN42026-03-24
00628101631680OhioHS-06IV-DHDHN4HS-06IV-DHDHN42026-03-24
00628101631703OhioHS-25SA-DHDHC4HS-25SA-DHDHC42026-03-24
00628101631710OhioHS-30SA-DHDHC4HS-30SA-DHDHC42026-03-24
00628101631727OhioHS-08UO-CFF4N4HS-08UO-CFF4N42026-03-24
00628101631734OhioHS-08UW-F4CMN5HS-08UW-F4CMN52026-03-24
00628101631741OhioHS-20UO-F4CMN4HS-20UO-F4CMN42026-03-24
00628101631758OhioHS-20UW-CFF4N5HS-20UW-CFF4N52026-03-24
00628101631802OhioHS-45UW-OFOMC4HS-45UW-OFOMC42026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08435510679101TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510679767TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510679774TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510679866TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510679873TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680039TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680046TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680053TITANIUM VAC REGHERSILL SLKDP2026-01-07
00850027043814Precision MedicalPrecision Medical, Inc.KDP2026-01-05
10197344143757MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-12-12
10197344143580MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143597MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143603MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143610MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143627MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143634MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
10197344143641MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-08-14
00850027043692Precision MedicalPrecision Medical, Inc.KDP2025-07-16
10197344146031MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-06-19
10197344146796MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-06-19
10197344134335MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-02-10
10197344134601MEDLINEMEDLINE INDUSTRIES, INC.KDP2025-02-10
10816286021168BOEHRINGER® Offset Mount - Four InchesBOEHRINGER LABORATORIES, LLCKDP2024-12-31
10193489131390MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-10-31
10193489131406MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-10-31
10193489148282MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-10-31
10197344110087MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-07-25
10197344101740MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-07-22
10197344101757MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-07-16
10197344098996MEDLINEMEDLINE INDUSTRIES, INC.KDP2024-07-11