Vibralung Patient Change Kit
Catalogue number 9640, listed by Westmed, Inc., United States, under Percussor, Powered-Electric. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Chongqing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
Record
| Listed by | Westmed, Inc., United States |
|---|---|
| FDA product code | BYI |
| Device type | Percussor, Powered-Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5665 |
| Establishment | Contract manufacturer, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K133057 |
| Record published | 2016-12-15 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -25 to 70 °C; Storage environment humidity 0 to 93 % RH |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9640 | In distribution |
Same Product Code
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| The Vest®System | Hill-Rom Services Pte, Ltd. | 97 |
| AffloVest | Tactile Systems Technology Inc | 39 |
| ClearChest® | Respiratory Technologies, Inc. | 31 |
| AffloVest | Movair, Inc. | 7 |
| Portex | ICU Medical, Inc | 4 |
| The Vest APX System | Hill-Rom Services Pte, Ltd. | 3 |
| Vibralung® | Westmed, Inc. | 3 |
| Frequencer | Dymedso, Inc. | 3 |
| Vibralung Patient Kit | Westmed, Inc. | 2 |
Showing 12 of 34. All products under Percussor, Powered-Electric
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.