Precision Medical Inc.
PM3600 Series, High Flow Continuous Vacuum Regulator, Export, Pole C, Medtronic
4manufacturers in China registered for this device type
26catalogue 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 | 2024-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2016-02-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM3600D SERIES | In distribution | |
| PM3500 SERIES | In distribution | |
| PM3200E SERIES | In distribution | |
| PM3300 SERIES | In distribution | |
| PS3400 | In distribution | |
| PM3000HV SERIES | In distribution | |
| PS3300 SERIES | In distribution | |
| PM3300 | In distribution | |
| PM3400 SERIES | In distribution | |
| PM3100D SERIES | In distribution | |
| PS3100 SERIES | In distribution | |
| PM9100 SERIES | In distribution | |
| PS3300D SERIES | In distribution | |
| PM3100HV SERIES | In distribution | |
| PM3000D SERIES | In distribution | |
| PS3300HV SERIES | In distribution | |
| PM3500D SERIES | In distribution | |
| PM3600 SERIES | In distribution | |
| PS3100HV SERIES | In distribution | |
| PM3000 SERIES | In distribution | |
| PM3100 SERIES | In distribution | |
| PS3000 SERIES | In distribution | |
| PM3600EPCME | In distribution | |
| PS3000HV SERIES | In distribution | |
| PM3300HV SERIES | In distribution | |
| PS3600 | 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 |
| Vacuum Regulator | Precision Medical Technologies | 42 |
| Amico Patient Care Corporation | Amico Patient Care Corporation | 32 |
| 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.