Sscor DCell
Catalogue number DM10-001, listed by Sscor, Inc., United States, under Pump, Portable, Aspiration (Manual Or Powered). 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (1), elsewhere (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Shenzhen BI-Rich Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Shenzhen Desida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Zhongshan A&E Machinery Industry Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Dikaku Industrial Co., Limited | Hong Kong | Hong Kong | Private-label distributor | 9 |
| Medcodes Healthcare (Shenzhen) Limited | Shenzhen | Guangdong | Manufacturer | 9 |
| Shenzhen Root Innovation Technology Co., Ltd. | Shenzhen | Guangdong | Specification developer | 8 |
| Hetaida Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 8 |
| Zhongshan A&J Medical Equipment Co., Ltd. | Guangdong | Guangdong | Manufacturer | 7 |
Showing 12 of 14. All 14 manufacturers in China registered for Pump, Portable, Aspiration (Manual Or Powered)
Record
| Listed by | Sscor, Inc., United States |
|---|---|
| FDA product code | BTA |
| Device type | Pump, Portable, Aspiration (Manual Or Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2017-02-13 |
| Record revised | 2019-08-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | serial number |
| Packaging | Carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DM10-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R&D Batteries, Inc. | R & D Batteries, Inc. | 104 |
| Gomco | Allied Medical LLC | 62 |
| Pump, Portable, Aspiration (Manual Or Powered) | Söring GmbH | 23 |
| Silicone tubing | Medela LLC | 10 |
| Grownsy | Oak Tech LLC | 8 |
| Nasal aspirator | Shenzhen Dongjiang Technology Co., Ltd. | 8 |
| Thopaz | Medela LLC | 6 |
| Precision Medical Inc. | Precision Medical Technologies | 6 |
| Basen | Dongguan Yiyingmei Technology Co., Ltd. | 6 |
| V7 | Hersill SL | 6 |
| Care-E-VAC | Hersill SL | 6 |
| Sscor Quickdraw® | Sscor, Inc. | 5 |
Showing 12 of 216. All products under Pump, Portable, Aspiration (Manual Or Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K041154 | 2004-05-18 |
| K964997 | 1997-03-05 |
| K952632 | 1995-06-16 |
| K945929 | 1994-12-22 |
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 |
|---|---|---|---|---|---|
| 2005-01-06 | Not classified | Other | Reports from medical professionals that SSCOR suction device has not performed as intended. Firm’s investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction. | 16 | 2011-06-13 |
| 2005-01-06 | Not classified | Other | Reports from medical professionals that SSCOR suction device has not performed as intended. Firm’s investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction. | 196 | 2011-06-13 |
| 2005-01-06 | Not classified | Other | Reports from medical professionals that SSCOR suction device has not performed as intended. Firm’s investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction. | 55 | 2011-06-13 |
| 2005-01-06 | Not classified | Other | Reports from medical professionals that SSCOR suction device has not performed as intended. Firm’s investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction. | 39 | 2011-06-13 |
| 2005-01-06 | Not classified | Other | Reports from medical professionals that SSCOR suction device has not performed as intended. Firm’s investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction. | 378 | 2011-06-13 |
| 2005-01-06 | Not classified | Other | Reports from medical professionals that SSCOR suction device has not performed as intended. Firm’s investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction. | 30 | 2011-06-13 |
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.