Suction Jar Polysulfone 2l
Catalogue number 077.0120, listed by Medela LLC, United States, under Pump, Portable, Aspiration (Manual Or Powered). 14 manufacturers in China are registered for this product 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 | Medela LLC, United States |
|---|---|
| FDA product code | BTA |
| Device type | Pump, Portable, Aspiration (Manual Or Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K130123 |
| Record published | 2016-10-24 |
| Record revised | 2025-11-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 077.0120 | 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 |
|---|---|
| K153663 | 2016-05-18 |
| K141553 | 2014-08-25 |
| K130123 | 2013-10-11 |
| K130210 | 2013-03-15 |
| K080212 | 2008-07-23 |
| K061205 | 2006-06-21 |
| K043544 | 2005-01-07 |
| K033179 | 2003-10-15 |
| K021368 | 2002-05-15 |
| K983552 | 1999-01-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medela LLC | 510(k) number | 2020-12-02 | Class II | Process control | Incorrect expiration date of “2023-07-24” on label of sterile tubing. Correct expiration date should be “2021-07-24”. | 6,244 units | 2024-06-17 |
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.