Rusch
Manual Pulmonary Resuscitator With Oxygen reservior tubing, swivel connector, medication Port, Peep connector and infant mask
8manufacturers in China registered for this device type
19catalogue numbers in this listing
1recall
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K993194 |
| Record published | 2019-06-06 |
| Record revised | 2025-01-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 60 °C; Handling environment temperature -40 to 60 °C |
| Packaging | Box of 6, case of 24, case of 12, case of 50, bpg |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN914333 | In distribution | |
| IPN914334 | In distribution | |
| IPN914335 | In distribution | |
| IPN914336 | In distribution | |
| IPN929078 | LIFESAVER® Neonate Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN914331 | In distribution | |
| IPN929084 | LIFESAVER® Adult Manual Resuscitator with Pressure Relief Valve, Mask and Flow Diverter | In distribution |
| IPN929085 | LIFESAVER® Adult Manual Resuscitator with Diverter and Valved Mask | In distribution |
| IPN929083 | LIFESAVER® Adult Manual Resuscitator with PEEP Valve and Mask | In distribution |
| IPN929086 | LIFESAVER® Adult Manual Resuscitator Foldable with Mask and Flow Diverter | In distribution |
| IPN929077 | In distribution | |
| IPN929079 | LIFESAVER® Neonate Manual Resuscitator with PEEP Valve and Mask | In distribution |
| IPN929076 | In distribution | |
| IPN929080 | LIFESAVER® Pediatric Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN929082 | LIFESAVER® Adult Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN929075 | In distribution | |
| IPN929087 | In distribution | |
| IPN914332 | In distribution | |
| IPN929081 | LIFESAVER® Pediatric Manual Resuscitator with PEEP Valve and Mask | In distribution |
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)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2015-05-14 | Class I | Nonconforming Material/Component | The intake port may be blocked which can cause the bag to fail to fill. | 9,333 units | 2024-05-13 |
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.