Percussionaire
Phasitron 5 Inline Valve
Who Else Makes It
Concentrated in Guangdong (14), Zhejiang (8), Jiangsu (3). 7 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 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Dongguan Plastiflex Hose Technology Ltd | Dongguan | Guangdong | Contract manufacturer | 3 |
| Worldcross Industries Co., Ltd. | Dong Yang | Zhejiang | Contract manufacturer | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Guangzhou Schauenburg-Truplast Hose Technology Ltd. | Guangzhou | Guangdong | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Tiger Medical Group | Shanghai | Shanghai | Specification developer | 38 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
Showing 12 of 33. All 33 manufacturers in China registered for Set, Tubing And Support, Ventilator (W Harness)
Record
| Listed by | Percussionaire Corp., United States |
|---|---|
| FDA product code | BZO |
| Device type | Set, Tubing And Support, Ventilator (W Harness) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5975 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P5-TEE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 85 |
| Hudson RCI | Teleflex Medical LLC | 82 |
| Classic RT | Plastiflex Group NV | 63 |
| INOmax | Mallinckrodt Manufacturing LLC | 37 |
| AirLife™ | Airlife, Inc. | 26 |
| Vadi Medical | Vadi Medical Technology Co., Ltd. | 17 |
| Ventilator Circuit | King Systems Corporation. | 16 |
| Wellead Oxygen Tubing | Well Lead Medical Co., Ltd. | 15 |
| Gas Sampling Line | Westmed, Inc. | 15 |
| Breathing circuit set, coaxial | Hamilton Medical AG | 14 |
| Create Biotech | Create Biotech Co., Ltd. | 13 |
| CPAP Tubing | Exceleron Medical, LLC | 10 |
Showing 12 of 356. All products under Set, Tubing And Support, Ventilator (W Harness)
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Percussionaire Corp. | UDI-DI | 2025-09-17 | Class I | Device Design | IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don’t use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to | 59160 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-08-21 | Class I | Device Design | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. | 2523 units |
| 2024-08-21 | Class I | Device Design | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. | 50,460 units |
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.