AirLife
Pediatric Manual Resuscitator, 40"(1.0m) Oxygen ResevoirTubing, Pediatric Mask, Pressure Limiting Valve with Lock, 7' O2 tubing
8manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (4), Zhejiang (1), Guangdong (1). 5 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 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
Record
| Listed by | Carefusion, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-10-24 |
| Record revised | 2024-05-21 (version 5) |
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, expiry date |
| Storage | Storage environment temperature -40 to 123 °F |
| Packaging | Case of 6, case of 12, case of 10 |
| Sizes | Weight 240 to 570 g; total volume 280 to 1500 ml |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2K7010 | Weight 435.00 g | Withdrawn |
| 2K7013 | Weight 435.00 g | Withdrawn |
| 2K7001 | Weight 407.00 g | Withdrawn |
| 2K8012 | Withdrawn | |
| 2K7202 | Weight 240.00 g | Withdrawn |
| 2K7003 | Weight 407.00 g | Withdrawn |
| 2K7004 | Weight 407.00 g | Withdrawn |
| 2K7012 | Weight 570 g | Withdrawn |
| 2K7008 | Weight 407.00 g | Withdrawn |
| 2K7104 | Weight 435.00 g | Withdrawn |
| 2K7000 | Weight 407.00 g | Withdrawn |
| 2K7011 | Weight 435.00 g | Withdrawn |
| 2K7100 | Weight 240.00 g | Withdrawn |
| 2K8013 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 405 |
| CPR-2 Bag | Mercury Medical Enterprises, LLC | 231 |
| CPR Bag | Mercury Medical Enterprises, LLC | 187 |
| Vital Signs™ | Airlife, Inc. | 102 |
| Medline | Medline Industries, Inc. | 78 |
| Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 74 |
| Spur® II Adult ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 66 |
| Hudson RCI | Teleflex Medical LLC | 56 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53 |
| Portex | ICU Medical, Inc | 45 |
| Spur® II Infant ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 45 |
| Curaplex® | Bound Tree Medical, LLC | 38 |
Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)
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.