Vacuum Regulator
PM3300 Series, Vac Reg, Intermittent, 300MMHG w/PM9100 Subglottic & Vac Trap
4manufacturers in China registered for this device type
42catalogue 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 | 2016-02-18 |
| Record revised | 2024-06-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date, serial number |
| Distribution end date | 2021-04-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS3300 series w/ Vac Trap | In distribution | |
| PM3600D series w/ Vac Trap | In distribution | |
| PM3500 series w/ Vac Trap | In distribution | |
| PM3400 series w/ Vac Trap | In distribution | |
| PM3400D SERIES | In distribution | |
| PM3100HV series w/ PM9100 | In distribution | |
| PM3300DHV series w/ Vac Trap | In distribution | |
| PM3300HV series w/PM9100 | In distribution | |
| PS3400D | In distribution | |
| PM3000 series w/Vac Trap | In distribution | |
| PM3300 series w/ Vac Trap | In distribution | |
| PM3000DHV SERIES | In distribution | |
| PM3300D SERIES | In distribution | |
| PM3100 series w/ Vac Trap | In distribution | |
| PM300HV series w/ Vac Trap | In distribution | |
| PS3300DHV SERIES | In distribution | |
| PM3300HV series w/PM9100 & Vac Trap | In distribution | |
| PM3100HV series w/ Vac Trap | In distribution | |
| PM3000HV series w/PM9100 | In distribution | |
| PM3300HV series w/ Vac Trap | In distribution | |
| PS300DHV SERIES w/ Vac Trap | In distribution | |
| PM3100DHV SERIES | In distribution | |
| PM3300DHV SERIES | In distribution | |
| PM3600 series w/ Vac Trap | In distribution | |
| PS3300D series w/ Vac Trap | In distribution | |
| PM3300 series w/ PM9100 | In distribution | |
| PM3000 series w/PM9100 | In distribution | |
| PM3100DHV series w/ Vac Trap | In distribution | |
| PM3300D series w/ Vac Trap | In distribution | |
| PM3400D series w/ Vac Trap | In distribution | |
| PS3300HV series w/ Vac Trap | In distribution | |
| PS3400D series w/ Vac Trap | In distribution | |
| PM3100 series w/ PM9100 | In distribution | |
| PS3500 | Withdrawn | |
| PS3100D | Withdrawn | |
| PS3000DHV | Withdrawn | |
| PM3600DBM | Withdrawn | |
| PS3100DHV | Withdrawn | |
| PS3500D | Withdrawn | |
| PM3100DHVBM | Withdrawn | |
| PS3000D | Withdrawn | |
| PS3600D | Withdrawn |
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 |
| 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
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.