Sure-Trap
Overflow Safety Trap
4manufacturers in China registered for this device type
2catalogue 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 | 2017-09-25 |
| Record revised | 2020-04-30 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Packaging | Carton of 50, carton of 25, carton of 12 |
| Distribution end date | 2020-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70365 | In distribution | |
| 70365 | Withdrawn |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 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 |
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.