Rusch
Neoprene Pecan Shaped Breathing Bag with 22 mm neck insert
28manufacturers in China registered for this device type
56catalogue 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BTC |
| Device type | Bag, Reservoir |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5320 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-24 |
| Record revised | 2025-08-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Packaging | Box of 100, box of 65, case of 20, case of 35, case of 65, case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN913373 | In distribution | |
| IPN044014 | In distribution | |
| IPN043945 | In distribution | |
| IPN045242 | In distribution | |
| IPN913345 | In distribution | |
| IPN924574 | In distribution | |
| IPN043865 | In distribution | |
| IPN924573 | In distribution | |
| IPN045568 | In distribution | |
| IPN913344 | In distribution | |
| IPN924576 | In distribution | |
| IPN045243 | In distribution | |
| IPN046007 | In distribution | |
| IPN045236 | In distribution | |
| IPN913382 | In distribution | |
| IPN045240 | In distribution | |
| IPN913348 | In distribution | |
| IPN043853 | In distribution | |
| IPN913370 | In distribution | |
| IPN043856 | In distribution | |
| IPN913350 | In distribution | |
| IPN913343 | In distribution | |
| IPN045237 | In distribution | |
| IPN046006 | In distribution | |
| IPN913381 | In distribution | |
| IPN044016 | In distribution | |
| IPN045185 | In distribution | |
| IPN043854 | In distribution | |
| IPN049987 | In distribution | |
| IPN913366 | In distribution | |
| IPN045239 | In distribution | |
| IPN913372 | In distribution | |
| IPN913349 | In distribution | |
| IPN913352 | In distribution | |
| IPN913351 | In distribution | |
| IPN913383 | In distribution | |
| IPN046008 | In distribution | |
| IPN044012 | In distribution | |
| IPN046867 | In distribution | |
| IPN913368 | In distribution | |
| IPN045238 | In distribution | |
| IPN049986 | In distribution | |
| IPN924575 | In distribution | |
| IPN045244 | In distribution | |
| IPN913342 | In distribution | |
| IPN046868 | In distribution | |
| IPN913365 | In distribution | |
| IPN045241 | In distribution | |
| IPN913367 | In distribution | |
| IPN913374 | In distribution | |
| IPN044015 | In distribution | |
| IPN044013 | In distribution | |
| IPN913346 | In distribution | |
| IPN913371 | In distribution | |
| IPN049937 | In distribution | |
| IPN043855 | 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 |
| 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 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
Showing 12 of 160. All products under Bag, Reservoir
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-15 | Class II | Employee error | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. | 107962 units | 2020-10-05 |
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.