VentStar Bag Set (P) 110
Catalogue number MP00384, listed by Drägerwerk AG & Co. KGaA, Germany, under Bag, Reservoir. 28 manufacturers in China are registered for this product code.
28manufacturers in China registered for this device type
1catalogue number
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 | Drägerwerk AG & Co. KGaA, Germany |
|---|---|
| FDA product code | BTC |
| Device type | Bag, Reservoir |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5320 |
| Premarket notification | Exempt |
| Record published | 2015-10-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MP00384 | 25 | 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 Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Draeger, Inc. | UDI-DI | 2023-04-17 | Class I | Process control | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. | 25 units | 2024-09-03 |
| Draeger, Inc. | UDI-DI | 2023-04-17 | Class I | Process control | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. | 25 units | 2024-09-03 |
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.