3b Medical, Inc.
3B Medical, Inc's Rio Nasal Pillow Mask All Size Kit includes the nasal mask, headgear and nasal pillow cushions in small, medium and large This mask is for use with a CPAP or bi-level…
3B Medical, Inc’s Rio Nasal Pillow Mask All Size Kit includes the nasal mask, headgear and nasal pillow cushions in small, medium and large This mask is for use with a CPAP or bi-level machine.
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (2), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Hunan Beyond Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 3 |
| Shanghai Baron Technologies Co Ltd | Shanghai | Shanghai | Contract manufacturer | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Zhejiang Baron Technologies Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Resvent Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Showing 12 of 18. All 18 manufacturers in China registered for Ventilator, Non-Continuous (Respirator)
Record
| Listed by | 3B Medical Inc, United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-08-18 |
| Record revised | 2026-03-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-03-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RO2001 | Withdrawn | |
| AE6030 | Withdrawn | |
| RO1001 | Withdrawn | |
| ELA2001 | Withdrawn | |
| RO5010 | Withdrawn | |
| ELA6010 | Withdrawn | |
| RO3001 | Withdrawn | |
| RO1003 | Withdrawn | |
| AE1003 | Withdrawn | |
| RO1000 | Withdrawn | |
| RO3002 | Withdrawn | |
| AE6010 | Withdrawn | |
| AE1002 | Withdrawn | |
| EO2001 | Withdrawn | |
| EO6020 | Withdrawn | |
| RO3003 | Withdrawn | |
| RO1002 | Withdrawn | |
| RO5020 | Withdrawn | |
| AE2001 | Withdrawn | |
| EO1002 | Withdrawn | |
| AE6020 | Withdrawn | |
| EO6030 | Withdrawn | |
| ELA6020 | Withdrawn | |
| ELA6030 | Withdrawn | |
| EO1003 | Withdrawn | |
| ELA1003 | Withdrawn | |
| EO6010 | Withdrawn | |
| EO1001 | Withdrawn | |
| AE1001 | Withdrawn | |
| RO5030 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 386 |
| DreamWear | Respironics Inc. | 183 |
| REMstar System One 60 Series | Respironics Inc. | 163 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 152 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 136 |
| Ventilator, Non-Continuous (Respirator) | Hans Rudolph, Inc. | 115 |
| BiPAP System One 60 Series | Respironics Inc. | 105 |
| Ventilator, Non-Continuous (Respirator) | Salter Labs | 85 |
| BiTrac Select | Pulmodyne Inc. | 79 |
| Yuwell Sleep Apnea Breathing Therapy Mask | Suzhou Yuyue Medical Technology Co., Ltd. | 76 |
| AF541 | Respironics Inc. | 71 |
| CPAP Masks | Sunset Healthcare Solutions, Inc. | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212263 | 2022-03-25 |
| K201620 | 2021-01-29 |
| K160127 | 2016-11-10 |
| K153387 | 2016-09-08 |
| K141770 | 2015-04-22 |
| K133769 | 2014-08-25 |
| K131901 | 2013-12-23 |
| K132967 | 2013-12-06 |
| K131707 | 2013-08-22 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-06-15 | Class II | Labeling Change Control | Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). | 375 |
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.