Vital Signs™
Vital Signs™ Manual Ventilation Components for ABS Bag Arm, Disposable 0.9 m/36 in With manual bag, 3 L and ABS Bag arm connector
28manufacturers in China registered for this device type
17catalogue numbers in this listing
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 | AirLife Finland Oy, Finland |
|---|---|
| FDA product code | BTC |
| Device type | Bag, Reservoir |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5320 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-01 |
| Record revised | 2025-10-02 (version 7) |
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 |
| Packaging | Case of 20, pack of 20 |
| Distribution end date | 2025-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M1019521 | In distribution | |
| M1212556 | In distribution | |
| M1019521 | In distribution | |
| M1019523 | In distribution | |
| M1019517 | In distribution | |
| M1019519 | In distribution | |
| M1036388 | In distribution | |
| M1019523 | In distribution | |
| M1036388 | In distribution | |
| M1036387 | In distribution | |
| M1019528 | In distribution | |
| M1036386 | In distribution | |
| M1036386 | In distribution | |
| M1019517 | In distribution | |
| M1036387 | In distribution | |
| M1019519 | In distribution | |
| M1036385 | Withdrawn |
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 |
| 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
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.