DeVilbiss
Part Sleep Flow Generator Accessories Product Description HEATER BOTTOM COVER W/FOAM
18manufacturers in China registered for this device type
136catalogue numbers in this listing
4510(k) clearances naming this product code
2recalls on this 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 | DeVilbiss Healthcare LLC., United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-08-08 |
| Record revised | 2026-07-31 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C |
| Packaging | Pack of 4 |
| Distribution end date | 2024-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DV53D-LA | Withdrawn | |
| DV5C-601 | Withdrawn | |
| DV57D-673 | Withdrawn | |
| DV55D-HH-S | Withdrawn | |
| DV64A | Withdrawn | |
| DV53D-HH-S2 | Withdrawn | |
| DV55SE | Withdrawn | |
| DV55D-673 | Withdrawn | |
| DV5C-614 | Withdrawn | |
| DV5MB | Withdrawn | |
| DV54NE-P | Withdrawn | |
| DV53D-HH-HT | Withdrawn | |
| DV53NE | Withdrawn | |
| DV55D-LA | Withdrawn | |
| DV54SE-HH | Withdrawn | |
| DV51SE | Withdrawn | |
| DV55I-670 | Withdrawn | |
| DV54D-673 | Withdrawn | |
| DV64E | Withdrawn | |
| DV5H-602 | Withdrawn | |
| DV5M | Withdrawn | |
| DV54UK | Withdrawn | |
| DV53BR | Withdrawn | |
| DV51BR | Withdrawn | |
| DV51D-R | Withdrawn | |
| DV51D-HH-S | Withdrawn | |
| DV53D-R | Withdrawn | |
| DV54D-R | Withdrawn | |
| 9352g | Withdrawn | |
| DV57D-LA | Withdrawn | |
| DV55UK | Withdrawn | |
| DV64D | Withdrawn | |
| 9354GLR | Withdrawn | |
| DV55D-HH-HT | Withdrawn | |
| DV55D | Withdrawn | |
| 9354GSR | Withdrawn | |
| DV53D-HH-S-HT | Withdrawn | |
| DV63A | Withdrawn | |
| DV55D-HH-S2 | Withdrawn | |
| DV63D | Withdrawn | |
| DV63E | Withdrawn | |
| DV57D | Withdrawn | |
| DV53BR-HH | Withdrawn | |
| DV51D-S | Withdrawn | |
| 9354sr | Withdrawn | |
| DV5H-608 | Withdrawn | |
| DV55BR-HH | Withdrawn | |
| 9352gs | Withdrawn | |
| DV54BR-HH | Withdrawn | |
| DV55UK-UP | Withdrawn | |
| DV51D | Withdrawn | |
| DV54BR | Withdrawn | |
| DV54D | Withdrawn | |
| DV54D-S | Withdrawn | |
| 9352gl | Withdrawn | |
| DV57D-HH-S-HT | Withdrawn | |
| DV53D | Withdrawn | |
| DV55NE-HH | Withdrawn | |
| DV53SE | Withdrawn | |
| DV57NE | Withdrawn | |
| DV57BR-HH | Withdrawn | |
| DV54UK-P | Withdrawn | |
| DV6PD | Withdrawn | |
| DV55D-HH-LA | Withdrawn | |
| DV57D-HH-HT | Withdrawn | |
| DV51D-HH-S-HT | Withdrawn | |
| DV5H-600 | Withdrawn | |
| 9352glr | Withdrawn | |
| DV54UK-HH | Withdrawn | |
| DV57D-S | Withdrawn | |
| DV5C | Withdrawn | |
| DV53UK | Withdrawn | |
| DV57SE-HH | Withdrawn | |
| DV54SE | Withdrawn | |
| DV54D-HH | Withdrawn | |
| DV55UK-HH | Withdrawn | |
| DV51NE | Withdrawn | |
| DV55NE | Withdrawn | |
| DV53SE-HH | Withdrawn | |
| DV51BR-HH | Withdrawn | |
| DV51UK-HH | Withdrawn | |
| DV51SE-HH | Withdrawn | |
| 9354GLR | Withdrawn | |
| DV6WM-NA | Withdrawn | |
| DV54D-HH-S-HT | Withdrawn | |
| 9354DR | Withdrawn | |
| DV57D-R | Withdrawn | |
| DV51D-HH | Withdrawn | |
| DV51UK | Withdrawn | |
| DV57UK | Withdrawn | |
| DV53D-HH-S | Withdrawn | |
| 9352s | Withdrawn | |
| DV5H-605 | Withdrawn | |
| DV6C | Withdrawn | |
| DV54D-HH-S2 | Withdrawn | |
| DV6HH | Withdrawn | |
| DV57D-HH-LA | Withdrawn | |
| DV57D-HH-S2 | Withdrawn | |
| DV54D-LA | Withdrawn | |
| DV55BR | Withdrawn | |
| DV51D-HH-HT | Withdrawn | |
| 9354G | Withdrawn | |
| 7351D-647 | Withdrawn | |
| DV53D-S | Withdrawn | |
| DV51D-LA | Withdrawn | |
| DV54SE | Withdrawn | |
| 9354GL | Withdrawn | |
| DV54D-HH-HT | Withdrawn | |
| 9354s | Withdrawn | |
| DV55D-S | Withdrawn | |
| DV55D-HH-S-HT | Withdrawn | |
| DV54D-HH-S | Withdrawn | |
| DV57SE | Withdrawn | |
| DV51D-HH-LA | Withdrawn | |
| 9352lr | Withdrawn | |
| DV53D-HH | Withdrawn | |
| DV55D-R | Withdrawn | |
| DV5HH | Withdrawn | |
| DV57D-HH-S | Withdrawn | |
| DV57UK-HH | Withdrawn | |
| DV57D-HH-S-HT | Withdrawn | |
| DV53D-HH-LA | Withdrawn | |
| DV55D-HH | Withdrawn | |
| DV5H-603 | Withdrawn | |
| DV54D-HH-LA | Withdrawn | |
| DV54SE-P | Withdrawn | |
| DV57D-HH | Withdrawn | |
| 9352gsr | Withdrawn | |
| DV51D-HH-S | Withdrawn | |
| DV57BR | Withdrawn | |
| DV55UK-UP-HH | Withdrawn | |
| 9352sr | Withdrawn | |
| 9354GL | Withdrawn | |
| 9352l | Withdrawn | |
| DV55SE-HH | Withdrawn | |
| 9354DR | 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 |
| 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 |
| Hudson RCI | Teleflex Medical LLC | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152810 | 2016-01-21 |
| K143677 | 2015-09-18 |
| K140880 | 2014-08-04 |
| K112220 | 2011-11-22 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-05-13 | Class III | Software Manufacturing/Software Deployment | A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as “RUN-TEST”. | 1809 | 2014-12-02 |
| 2011-03-11 | Not classified | Nonconforming Material/Component | Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture. | 210 | 2016-10-24 |
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.