BiTrac Select
79 catalogue numbers from 10161774, listed by Pulmodyne Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
79catalogue numbers in this listing
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 | Pulmodyne Inc., United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K023683 |
| Record published | 2025-04-11 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10161774 | Large | In distribution |
| 313-9555 | Adult Extra Large | In distribution |
| 313-9524 | XXS | In distribution |
| 313-9572 | Adult Medium | In distribution |
| 313-9573 | Adult Large | In distribution |
| 313-9513 | Adult Large | In distribution |
| 313-9593A | In distribution | |
| 313-9559 | Adult Extra Large | In distribution |
| 313-9582 | Adult Medium | In distribution |
| 313-9563 | Adult Large | In distribution |
| 313-9554 | Adult Small | In distribution |
| 10161832 | In distribution | |
| 10161780 | In distribution | |
| 10161782 | In distribution | |
| 313-9035W | Adult Extra Small | In distribution |
| 313-9523 | Adult Medium | In distribution |
| 313-9520 | Adult Medium | In distribution |
| 10161830 | XXS | In distribution |
| 313-9589 | Small | In distribution |
| 313-9578 | Adult Large | In distribution |
| 10161775 | Small | In distribution |
| 10161779 | In distribution | |
| 313-9557 | Adult Small | In distribution |
| 313-9533 | Adult Large | In distribution |
| 313-9562 | Adult Medium | In distribution |
| 313-9596 | In distribution | |
| 313-9512 | Adult Medium | In distribution |
| 313-9602 | In distribution | |
| 313-9591 | Large | In distribution |
| 313-9047W | Adult Medium | In distribution |
| 313-9558 | Adult Large | In distribution |
| 10161831 | XS | In distribution |
| 313-9590 | Adult Medium | In distribution |
| 313-9577A | Adult Medium | In distribution |
| 313-9503 | Adult Large | In distribution |
| 10161784 | In distribution | |
| 10161833 | XS | In distribution |
| 313-9552 | Adult Large | In distribution |
| 313-9541 | Adult Small | In distribution |
| 313-9594 | In distribution | |
| 313-9578A | Adult Large | In distribution |
| 313-9561 | Adult Small | In distribution |
| 313-9530 | Adult Extra Small | In distribution |
| 313-9598 | In distribution | |
| 313-9502 | Adult Medium | In distribution |
| 313-9577 | Adult Medium | In distribution |
| 313-9542 | Adult Medium | In distribution |
| 313-9514 | Adult Extra Large | In distribution |
| 313-9593 | In distribution | |
| 10161766 | Medium | In distribution |
| 313-9527 | XS | In distribution |
| 313-9576A | Adult Small | In distribution |
| 10161765 | Small | In distribution |
| 10161773 | Extra Large | In distribution |
| 313-9504 | Adult Extra Large | In distribution |
| 313-9068W | Adult Large | In distribution |
| 313-9532 | Adult Medium | In distribution |
| 313-9516 | Adult Medium | In distribution |
| 313-9525 | XS | In distribution |
| 313-9518 | Adult Extra Large | In distribution |
| 313-9526 | XXS | In distribution |
| 313-9517 | Adult Large | In distribution |
| 313-9515 | Adult Small | In distribution |
| 313-9066W | Adult Small | In distribution |
| 313-9576 | Adult Small | In distribution |
| 313-9501 | Adult Small | In distribution |
| 313-9036W | Adult Small | In distribution |
| 313-9571 | Adult Small | In distribution |
| 313-9067W | Adult Medium | In distribution |
| 313-9048W | Adult Large | In distribution |
| 313-9543 | Adult Large | In distribution |
| 10161767 | Large | In distribution |
| 313-9531 | Adult Small | In distribution |
| 313-9037W | Adult Medium | In distribution |
| 313-9581 | Adult Small | In distribution |
| 313-9580 | Adult Extra Small | In distribution |
| 10161768 | Extra Large | In distribution |
| 313-9583 | Adult Large | In distribution |
| 313-9511 | Adult Small | In distribution |
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 |
| 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)
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.