Boehringer® Sorenson Mount
Sorenson Mount
4manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
3recalls on this 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 | Boehringer Laboratories, LLC, United States |
|---|---|
| FDA product code | KDP |
| Device type | Regulator, Vacuum |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-01 |
| Record revised | 2018-08-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9084 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K013976 | 2002-01-08 |
| K933232 | 1994-03-28 |
| K853155 | 1985-10-16 |
| K850200 | 1985-03-04 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-08-01 | Not classified | Other | Condition exists that prevents complete shutoff of the valve | 1829 units | 2005-11-16 |
| 2005-08-01 | Not classified | Other | Condition exists that prevents complete shutoff of the valve | 1829 units | 2005-11-16 |
| 2005-08-01 | Not classified | Other | Condition exists that prevents complete shutoff of the valve | 1829 units | 2005-11-16 |
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.