Amvex Vacuum Regulator
VR-N2 series, VacReg, Neo Cont 2Mode 100mmHg, Ohio Analog Dual (mmHg & kPa)
4manufacturers in China registered for this device type
119catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Gentec (Shanghai) Corporation | Shanghai | Shanghai | Manufacturer | 12 |
Record
| Listed by | Ohio Medical LLC, United States |
|---|---|
| FDA product code | KDP |
| Device type | Regulator, Vacuum |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-08-23 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIB | In distribution | |
| C3P | In distribution | |
| C2L | In distribution | |
| P2N | In distribution | |
| CHA | In distribution | |
| C2H | In distribution | |
| NNN | In distribution | |
| CHP | In distribution | |
| LCD | In distribution | |
| PIP | In distribution | |
| C3D | In distribution | |
| LPA | In distribution | |
| LPD | In distribution | |
| C2P | In distribution | |
| N2B | In distribution | |
| CIP | In distribution | |
| NIB | In distribution | |
| LLH | In distribution | |
| LPN | In distribution | |
| PPP | In distribution | |
| LIN | In distribution | |
| N2D | In distribution | |
| LLL | In distribution | |
| N2N | In distribution | |
| L3D | In distribution | |
| P2P | In distribution | |
| C3N | In distribution | |
| I2H | In distribution | |
| C2D | In distribution | |
| LCN | In distribution | |
| LLB | In distribution | |
| L3L | In distribution | |
| CHH | In distribution | |
| NIA | In distribution | |
| PIH | In distribution | |
| PPD | In distribution | |
| P2D | In distribution | |
| N2A | In distribution | |
| PPA | In distribution | |
| N2L | In distribution | |
| N2H | In distribution | |
| I2L | In distribution | |
| PPL | In distribution | |
| LLA | In distribution | |
| PIA | In distribution | |
| NIH | In distribution | |
| LCA | In distribution | |
| C3L | In distribution | |
| NND | In distribution | |
| LIP | In distribution | |
| CIB | In distribution | |
| NNA | In distribution | |
| CHD | In distribution | |
| L2B | In distribution | |
| PPB | In distribution | |
| PPN | In distribution | |
| NIL | In distribution | |
| LLD | In distribution | |
| NNL | In distribution | |
| C2B | In distribution | |
| LIA | In distribution | |
| I2P | In distribution | |
| PIL | In distribution | |
| LPP | In distribution | |
| LLN | In distribution | |
| LIL | In distribution | |
| L2A | In distribution | |
| C3B | In distribution | |
| PID | In distribution | |
| L3H | In distribution | |
| PPH | In distribution | |
| C2A | In distribution | |
| CIN | In distribution | |
| P2B | In distribution | |
| LCB | In distribution | |
| LLP | In distribution | |
| LPL | In distribution | |
| L2N | In distribution | |
| NNH | In distribution | |
| NNB | In distribution | |
| L2L | In distribution | |
| C3H | In distribution | |
| N2P | In distribution | |
| L2P | In distribution | |
| LIB | In distribution | |
| C3A | In distribution | |
| LID | In distribution | |
| NNP | In distribution | |
| LPH | In distribution | |
| CIA | In distribution | |
| NIP | In distribution | |
| NIN | In distribution | |
| C2N | In distribution | |
| L3B | In distribution | |
| P2H | In distribution | |
| L3N | In distribution | |
| I2A | In distribution | |
| CIL | In distribution | |
| L2H | In distribution | |
| L3A | In distribution | |
| LPB | In distribution | |
| P2A | In distribution | |
| I2N | In distribution | |
| CHB | In distribution | |
| I2D | In distribution | |
| CIH | In distribution | |
| LCP | In distribution | |
| CID | In distribution | |
| L3P | In distribution | |
| LCL | In distribution | |
| L2D | In distribution | |
| CHN | In distribution | |
| LCH | In distribution | |
| I2B | In distribution | |
| PIN | In distribution | |
| NID | In distribution | |
| LIH | In distribution | |
| CHL | In distribution | |
| P2L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 409 |
| Gentec® | Gentec (Shanghai) Corporation | 254 |
| Vacutron | Allied Medical LLC | 56 |
| Ohio Medical Vacuum Regulator | Ohio Medical LLC | 55 |
| Vacuum Regulator | Precision Medical Technologies | 42 |
| Amico Patient Care Corporation | Amico Patient Care Corporation | 32 |
| Precision Medical Inc. | Precision Medical Technologies | 26 |
| Precision Medical | Precision Medical Technologies | 25 |
| Titanium VAC REG | Hersill SL | 8 |
| Veevo | Tenacore LLC | 8 |
| MediEvac+ | GCE, s.r.o. | 6 |
| Boehringer® Care 4™ Suction Regulator, Intermittent/Continuous, 0-200, off/ cont | Boehringer Laboratories, LLC | 2 |
Showing 12 of 94. All products under Regulator, Vacuum
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-12 | Class II | Employee error | Final quality control testing was not completed before the devices were distributed.. | 11 units | 2020-07-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.