SunMed
Test Lung Latex Free Green LG- Mercury Medical
28manufacturers in China registered for this device type
3catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (6), Fujian (4). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
Showing 12 of 28. All 28 manufacturers in China registered for Bag, Reservoir
Record
| Listed by | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | BTC |
| Device type | Bag, Reservoir |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5320 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-18 |
| Record revised | 2026-05-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Total volume 500 to 1000 ml |
| Distribution end date | 2027-05-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4-0050-50 | Total Volume 750 ml | In distribution |
| 4-0050-10M | Total Volume 1000 ml | In distribution |
| 4-0050-10 | Total Volume 500 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Breathing bags | Shandong Jinlai Huanhai Medical Technology Co., Ltd. | 120 |
| Portex | ICU Medical, Inc | 81 |
| AincA® | Anesthesia Associates, Inc. | 67 |
| Rusch | Teleflex Medical LLC | 56 |
| Medline Industries, Inc. | Medline Industries, Inc. | 55 |
| 6000 Ndgb | Hans Rudolph, Inc. | 29 |
| Breathing BAG | King Systems Corporation. | 27 |
| Vital Signs™ | AirLife Finland Oy | 17 |
| Hudson RCI | Teleflex Medical LLC | 16 |
| Bag, Reservoir | VBM Medizintechnik Gmbh | 10 |
| Breathing Bag | Westmed, Inc. | 10 |
| Mindray | GaleMed (Xiamen) Co., Ltd. | 9 |
Showing 12 of 160. All products under Bag, Reservoir
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 |
|---|---|---|---|---|---|
| 2007-12-05 | Not classified | Other | During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly. | 571, 500 units | 2008-10-15 |
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.