Hudson RCI
VOLUMETRIC EXERCISER For Maintaining and Improving Inspiratory Volume and Respiratory Fitness
3manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Ainengke Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Chinamed Products (China) Ltd. | Gaoyao District | Guangdong | Manufacturer | 8 |
| Shenzhen Gwode Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 2 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BWF |
| Device type | Spirometer, Therapeutic (Incentive) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5690 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K801199 |
| Record published | 2016-09-16 |
| Record revised | 2023-11-17 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12, box of 12, box of 10 |
| Distribution end date | 2025-10-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN045545 | Patient | In distribution |
| IPN045538 | In distribution | |
| IPN046864 | In distribution | |
| IPN045541 | Patient | In distribution |
| IPN045542 | Patient | In distribution |
| IPN049317 | Patient | In distribution |
| IPN045540 | Respiratory Exerciser Hudson RCI | In distribution |
| IPN044469 | In distribution | |
| IPN045543 | Patient | In distribution |
| IPN045539 | In distribution | |
| IPN049316 | Patient | In distribution |
| IPN049141 | Respiratory Exerciser Hudson RCI | In distribution |
| IPN049320 | Patient | In distribution |
| IPN049140 | In distribution | |
| IPN049318 | Patient | In distribution |
| IPN049321 | In distribution | |
| IPN049319 | Patient | In distribution |
| IPN042769 | In distribution | |
| IPN045544 | Patient | In distribution |
| IPN049311 | Withdrawn | |
| IPN049100 | Withdrawn | |
| IPN049101 | Withdrawn | |
| IPN049102 | Withdrawn | |
| IPN049105 | Withdrawn | |
| IPN049104 | Withdrawn | |
| IPN049142 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 42 |
| AirLife™ | Airlife, Inc. | 11 |
| AIM | Vitalograph Ireland Ltd. | 9 |
| AirLife | Carefusion | 8 |
| Prochamber Assembly | Respironics Respiratory Drug Delivery (Uk), Ltd. | 6 |
| Threshold | Respironics Respiratory Drug Delivery (Uk), Ltd. | 6 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| Hudson RCI | Medline Industries, Inc. | 5 |
| VersaPAP™ Positive Airway Pressure Device | Trudell Medical International | 4 |
| Curaplex | TRI-Anim Health Services, Inc. | 4 |
| Halyard | Owens & Minor Distribution, Inc. | 4 |
| McKesson | Mckesson Medical-Surgical Inc. | 3 |
Showing 12 of 67. All products under Spirometer, Therapeutic (Incentive)
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.