Ventilator, Non-Continuous (Respirator)
Utopia AV Full Face Mask - LG, (with Black Headgear), pack of 5
18manufacturers in China registered for this device type
85catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Salter Labs, 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 |
| 510(k) | K052249 |
| Record published | 2017-09-01 |
| Record revised | 2024-05-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Pack of 30, pack of 15, pack of 88, pack of 96, pack of 32, pack of 112 |
| Distribution end date | 2027-03-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UTO251 | In distribution | |
| PA401 | In distribution | |
| P430 | In distribution | |
| HYB513 | In distribution | |
| SM302 | In distribution | |
| XS301 | In distribution | |
| NAT325 | In distribution | |
| UTO253 | In distribution | |
| SYL201 | In distribution | |
| UTO255 | In distribution | |
| MD03 | In distribution | |
| BRV625 | In distribution | |
| PB402 | In distribution | |
| LG1001 | In distribution | |
| LG305 | In distribution | |
| HYB521 | In distribution | |
| SYL271 | In distribution | |
| MD1002 | In distribution | |
| SYL273 | In distribution | |
| LG05 | In distribution | |
| MP04 | In distribution | |
| HYB540 | In distribution | |
| BRV623 | In distribution | |
| SYL203 | In distribution | |
| SYL200 | In distribution | |
| K2A | In distribution | |
| ASP200 | In distribution | |
| BRV621 | In distribution | |
| BRV630 | In distribution | |
| SYL211 | In distribution | |
| BRV730 | In distribution | |
| NAT323 | In distribution | |
| BRV600 | In distribution | |
| MP304 | In distribution | |
| BRV700 | In distribution | |
| SYL213 | In distribution | |
| UTO253A | In distribution | |
| UTO251A | In distribution | |
| XL06 | In distribution | |
| NAT324 | In distribution | |
| MD303 | In distribution | |
| SYL230 | In distribution | |
| UTO255A | In distribution | |
| PD414 | Withdrawn | |
| ASP205 | Withdrawn | |
| ALO131 | Withdrawn | |
| XS1004 | Withdrawn | |
| PE405 | Withdrawn | |
| HYB500 | Withdrawn | |
| PE415 | Withdrawn | |
| ALO100 | Withdrawn | |
| HYB515 | Withdrawn | |
| ALO123 | Withdrawn | |
| XL1000 | Withdrawn | |
| ASP230 | Withdrawn | |
| ALO130 | Withdrawn | |
| HYB551 | Withdrawn | |
| ASP211 | Withdrawn | |
| NAT321 | Withdrawn | |
| HYB511 | Withdrawn | |
| NAT322 | Withdrawn | |
| ASP201 | Withdrawn | |
| HYB530 | Withdrawn | |
| HYB525 | Withdrawn | |
| HYB523 | Withdrawn | |
| PD404 | Withdrawn | |
| ALO121 | Withdrawn | |
| ASP215 | Withdrawn | |
| ALO135 | Withdrawn | |
| XS01 | Withdrawn | |
| PC403 | Withdrawn | |
| XL306 | Withdrawn | |
| PB412 | Withdrawn | |
| HYB553 | Withdrawn | |
| ASP203 | Withdrawn | |
| ALO133 | Withdrawn | |
| SM02 | Withdrawn | |
| NAT320 | Withdrawn | |
| PA411 | Withdrawn | |
| NAT326 | Withdrawn | |
| SM1003 | Withdrawn | |
| HYB555 | Withdrawn | |
| ALO125 | Withdrawn | |
| ASP213 | Withdrawn | |
| PC413 | 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 |
| 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 |
| Hudson RCI | Teleflex Medical LLC | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143700 | 2015-08-05 |
| K040202 | 2005-03-04 |
| K912434 | 1991-07-30 |
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.