Pedia
3 catalogue numbers from P001Y, listed by Pedia, United States, under Bag, Reservoir. 28 manufacturers in China are registered for this product code.
28manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
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 | Pedia, United States |
|---|---|
| FDA product code | BTC |
| Device type | Bag, Reservoir |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5320 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K181424 |
| Record published | 2023-02-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P001Y | In distribution | |
| P001B | In distribution | |
| P001P | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181424 | 2018-09-25 |
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.