R&D Batteries, Inc.
3.7 Volt / 6.0Ah Li-Ion - Retrofit
14manufacturers in China registered for this device type
104catalogue numbers in this listing
1510(k) clearance
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 | R & D Batteries, 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 | Contract manufacturer, Manufacturer |
| 510(k) | K942033 |
| Record published | 2024-01-01 |
| Record revised | 2025-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-02-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5545 | In distribution | |
| 5631 | In distribution | |
| 6029 | In distribution | |
| 6250 | In distribution | |
| 5820L | In distribution | |
| 6214-A | In distribution | |
| 6307 | In distribution | |
| 5181 | In distribution | |
| 5181-LI | In distribution | |
| 5881 | In distribution | |
| 6084-I | In distribution | |
| 6579 | In distribution | |
| 5181-LI-A | In distribution | |
| 6406 | In distribution | |
| 6185 | In distribution | |
| 6469 | In distribution | |
| 6094 | In distribution | |
| 5881-A | In distribution | |
| 5838 | In distribution | |
| 6187 | In distribution | |
| 6207 | In distribution | |
| 6693-A | In distribution | |
| 5377 | In distribution | |
| 6084-R | In distribution | |
| 6214-R | In distribution | |
| 6296 | In distribution | |
| 5896 | In distribution | |
| 5624-I | In distribution | |
| 6496-A | In distribution | |
| 6359 | In distribution | |
| 5860 | In distribution | |
| 5977 | In distribution | |
| 6698 | In distribution | |
| 5380 | In distribution | |
| 5898 | In distribution | |
| 6523-R | In distribution | |
| 5601 | In distribution | |
| 6635 | In distribution | |
| 6385 | In distribution | |
| 6354 | In distribution | |
| 5558 | In distribution | |
| 5035 | In distribution | |
| 5536-P | In distribution | |
| 5624-A | In distribution | |
| 5073 | In distribution | |
| 5626 | In distribution | |
| 6651 | In distribution | |
| 6084 | In distribution | |
| 5181-I | In distribution | |
| 6022 | In distribution | |
| 6214 | In distribution | |
| 6309 | In distribution | |
| 6419 | In distribution | |
| 6084-B | In distribution | |
| 6657 | In distribution | |
| 5015 | In distribution | |
| 6384 | In distribution | |
| 6085 | In distribution | |
| 6312 | In distribution | |
| 6619 | In distribution | |
| 6601 | In distribution | |
| 6312-A | In distribution | |
| 6087-I | In distribution | |
| 5158 | In distribution | |
| 6564 | In distribution | |
| 5965 | In distribution | |
| 0819-0012 | In distribution | |
| 5369 | In distribution | |
| 6312-R | In distribution | |
| 5070 | In distribution | |
| 5601-NiMh | In distribution | |
| 5997 | In distribution | |
| 5410 | In distribution | |
| 5016 | In distribution | |
| 6097 | In distribution | |
| 340-000-000 | In distribution | |
| 5384 | In distribution | |
| 5515 | In distribution | |
| 6600 | In distribution | |
| 5875-P | In distribution | |
| 6469-A | In distribution | |
| 6296-I | In distribution | |
| 5284 | In distribution | |
| 6636 | In distribution | |
| 6320 | In distribution | |
| 6208 | In distribution | |
| 6007 | In distribution | |
| 6598 | In distribution | |
| 5391-F2 | In distribution | |
| 5024 | In distribution | |
| 5624 | In distribution | |
| 5378 | In distribution | |
| 6597 | In distribution | |
| 5655 | In distribution | |
| 6467-A | In distribution | |
| 6048 | In distribution | |
| 6577 | In distribution | |
| 6467 | In distribution | |
| 5558-NiMh | In distribution | |
| 5149 | In distribution | |
| 6566 | Withdrawn | |
| 6596 | Withdrawn | |
| 6429 | Withdrawn | |
| 6599 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Heyvalue | Oak Tech LLC | 5 |
Showing 12 of 216. All products under Pump, Portable, Aspiration (Manual Or Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K942033 | 1994-06-28 |
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.