BiWaze Cough Dual Lumen Circuit With Mouthpiece
Catalogue number BC23387, listed by Abmrc LLC, United States, under Device, Positive Pressure Breathing, Intermittent. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
4510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Abmrc LLC, United States |
|---|---|
| FDA product code | NHJ |
| Device type | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-04-01 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BC23387 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoughAssist | Respironics Inc. | 44 |
| Percussionaire | Percussionaire Corp. | 40 |
| The MetaNeb®System | Hill-Rom Services Pte, Ltd. | 14 |
| The VitalCough®System | Hill-Rom Services Pte, Ltd. | 10 |
| Synclara Cough System | Hill-Rom Services Pte, Ltd. | 10 |
| Volara System | Hill-Rom Services Pte, Ltd. | 9 |
| Vocsn Patient Breathing Package | Ventec Life Systems, Inc. | 7 |
| Clearo | Breas Medical, Inc. | 6 |
| Maximus System | Hill-Rom Services Pte, Ltd. | 6 |
| BiWaze Clear Dual Lumen Circuit With Face Mask – Adult Small | Abmrc LLC | 3 |
| BiWaze Cough Dual Lumen Circuit With Face Mask – Adult Large | Abmrc LLC | 3 |
| The Vest APX System | Hill-Rom Services Pte, Ltd. | 2 |
Showing 12 of 32. All products under Device, Positive Pressure Breathing, Intermittent
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260604 | 2026-08-24 |
| K231728 | 2024-04-08 |
| K213564 | 2022-12-21 |
| K191912 | 2020-03-27 |
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.