NeoPAP Customer Trial Pack
Model # 1078535 – DI # B0361078535 – NeoPAP Bonnet XS – Qty 3; Model # 1078536 – DI # B0361078536 – NeoPAP Bonnet S – Qty 3; Model # 1078537 – DI # B0361078537 – NeoPAP Bonnet M – Qty 3;…
Model # 1078535 → DI # B0361078535 → NeoPAP Bonnet XS → Qty 3; Model # 1078536 → DI # B0361078536 → NeoPAP Bonnet S → Qty 3; Model # 1078537 → DI # B0361078537 → NeoPAP Bonnet M → Qty 3; Model # 1078538 → DI # B0361078538 → NeoPAP Bonnet L → Qty 2; Model # 1078539 → DI # B0361078539 → NeoPAP Bonnet XL → Qty 2; Model # 1110290 → DI # B0361110290 → NeoPAP Cannula XXS → Qty 2; Model # 1078611 → DI # B0361078611 → NeoPAP Cannula XS → Qty 2; Model # 1078612 → DI # B0361078612 → NeoPAP Cannula S → Qty 2; Model # 1078613 → DI # B0361078613 → NeoPAP Cannula M → Qty 2; Model # 1078614 → DI # B0361078614 → NeoPAP Cannula L → Qty 2; Model # 1078616 → DI # B0361078616 → NeoPAP Cannula XL → Qty 2; Model # 1078667 → DI # B0361078667 → NeoPAP Nasal Mask S → Qty 5; Model # 1078668 → DI # B0361078668 → NeoPAP Nasal Mask L → Qty 5; Model # 1078582 → DI # B0361078582 → NeoPAP Pressure Line & Sizing Kit → Qty 10
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 | Circadiance, United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K103410 |
| Record published | 2016-07-29 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1078602 | 45 | 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 |
| 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 |
|---|---|
| K162905 | 2017-03-15 |
| K151683 | 2016-04-05 |
| K130481 | 2013-05-24 |
| K120757 | 2012-04-24 |
| K092362 | 2009-11-02 |
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.