Precision Medical
PSX3500 Series,vac REG,CONT,2POSN,150MMHG,PRE-SET,DIGITAL
4manufacturers in China registered for this device type
25catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Precision Medical Technologies, United States |
|---|---|
| FDA product code | KDP |
| Device type | Regulator, Vacuum |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K944479 |
| Record published | 2024-05-10 |
| Record revised | 2024-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PMX3100HV | In distribution | |
| PSX3300 | In distribution | |
| PSX3100 | In distribution | |
| PMX3600D | In distribution | |
| PSX3600 | In distribution | |
| PM36PCCM | In distribution | |
| PMX3300 | In distribution | |
| PSX3000 | In distribution | |
| PMX3500D | In distribution | |
| PMX3000DHV | In distribution | |
| PMX3400D | In distribution | |
| PMX3300DHV | In distribution | |
| PMX3000HV | In distribution | |
| PMX3300HV | In distribution | |
| PMX3000D | In distribution | |
| PMX3000 | In distribution | |
| PMX3100D | In distribution | |
| PMX3100 | In distribution | |
| PMX3300D | In distribution | |
| PSX3500 | In distribution | |
| PSX3400 | In distribution | |
| PMX3500 | In distribution | |
| PMX3400 | In distribution | |
| PMX3100DHV | In distribution | |
| PMX3600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 409 |
| Gentec® | Gentec (Shanghai) Corporation | 254 |
| Amvex Vacuum Regulator | Ohio Medical LLC | 119 |
| 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K944479 | 1994-12-22 |
| K922817 | 1993-03-04 |
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.