Hudson RCI
REPLACEMENT PARTVALVE KITContains one (1) each: Exhalation Valve,Duckbill Valve, O-ring, Intake Valve andtwo (2) each: Reservoir Valve
8manufacturers in China registered for this device type
56catalogue 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) | K964719 |
| Record published | 2019-09-17 |
| Record revised | 2025-09-30 (version 15) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 60 °C |
| Packaging | Box of 6, case of 100, box of 10, case of 50, case of 24, case of 12 |
| Sizes | Length 1.18 to 8.27 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN039347 | LIFESAVER® Pediatric Manual Resuscitator with Flow Diverter | In distribution |
| IPN044933 | LIFESAVER® Neonate Manual Resuscitator with Flow Diverter | In distribution |
| IPN044937 | LIFESAVER® Pediatric Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN039350 | LIFESAVER® Adult Manual Resuscitator with Flow Diverter | In distribution |
| IPN044945 | PEEP Valve | In distribution |
| IPN039378 | In distribution | |
| IPN039354 | LIFESAVER® Adult Manual Resuscitator with Diverter and Valved Mask | In distribution |
| IPN044944 | PEEP Valve | In distribution |
| IPN044935 | LIFESAVER® Neonate Manual Resuscitator with PEEP Valve and Mask | In distribution |
| IPN039352 | LIFESAVER® Adult Manual Resuscitator with PEEP Valve and Mask | In distribution |
| IPN044930 | Length 8.27 in | In distribution |
| IPN029667 | PEEP Valve | In distribution |
| IPN044928 | Length 8.27 in | In distribution |
| IPN044943 | LIFESAVER® Adult Manual Resuscitator with Diverter and Valved Mask | In distribution |
| IPN039371 | In distribution | |
| IPN039361 | In distribution | |
| IPN044942 | LIFESAVER® Adult Manual Resuscitator with Pressure Relief Valve, Mask and Flow Diverter | In distribution |
| IPN044945 | Length 1.18 in | In distribution |
| IPN039362 | In distribution | |
| IPN044944 | PEEP Valve | In distribution |
| IPN039346 | LIFESAVER® Neonate Manual Resuscitator with PEEP Valve and Mask | In distribution |
| IPN039360 | In distribution | |
| IPN039355 | LIFESAVER® Adult Manual Resuscitator Foldable with Mask and Flow Diverter | In distribution |
| IPN039370 | In distribution | |
| IPN044940 | LIFESAVER® Adult Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN039356 | In distribution | |
| IPN039349 | LIFESAVER® Pediatric Manual Resuscitator with PEEP Valve and Mask | In distribution |
| IPN039345 | LIFESAVER® Neonate Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN039353 | LIFESAVER® Adult Manual Resuscitator with Pressure Relief Valve, Mask and Flow Diverter | In distribution |
| IPN044932 | Length 5.39 in | In distribution |
| IPN044936 | LIFESAVER® Pediatric Manual Resuscitator with Flow Diverter | In distribution |
| IPN044938 | LIFESAVER® Pediatric Manual Resuscitator with PEEP Valve and Mask | In distribution |
| IPN029668 | PEEP Valve | In distribution |
| IPN044941 | LIFESAVER® Adult Manual Resuscitator with PEEP Valve and Mask | In distribution |
| IPN044934 | LIFESAVER® Neonate Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN029669 | Positive End Expiratory Pressure (PEEP) Valve | In distribution |
| IPN039357 | In distribution | |
| IPN049365 | In distribution | |
| IPN039379 | In distribution | |
| IPN044931 | Length 5.39 in | In distribution |
| IPN039373 | In distribution | |
| IPN039348 | LIFESAVER® Pediatric Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN039374 | In distribution | |
| IPN039372 | In distribution | |
| IPN039365 | In distribution | |
| IPN039367 | In distribution | |
| IPN044528 | Positive End Expiratory Pressure (PEEP) Valve | In distribution |
| IPN044946 | LIFESAVER® Adult Manual Resuscitator Foldable with Mask and Flow Diverter | In distribution |
| IPN039351 | LIFESAVER® Adult Manual Resuscitator with Mask and Flow Diverter | In distribution |
| IPN039368 | In distribution | |
| IPN039366 | In distribution | |
| IPN039377 | In distribution | |
| IPN039359 | In distribution | |
| IPN044939 | LIFESAVER® Adult Manual Resuscitator with Flow Diverter | In distribution |
| IPN039344 | LIFESAVER® Neonate Manual Resuscitator with Flow Diverter | In distribution |
| IPN039364 | 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 |
| 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 |
| Vital Signs | Carefusion | 31 |
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.