Ventlab
Bi-Level Circuit for Resp Vision & STD30 Bi-Level w/o Tethered Connector
18manufacturers in China registered for this device type
36catalogue numbers in this listing
1510(k) clearance
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 | Ventlab, LLC, United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| 510(k) | K040726 |
| Record published | 2016-09-27 |
| Record revised | 2023-10-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: General Warehouse. Do not get wet. |
| Packaging | Box of 10, box of 25, box of 6, box of 20 |
| Sizes | Length 24 ft; outer diameter 22 mm |
| Distribution end date | 2023-10-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRO7140-T | In distribution | |
| cs9000 | In distribution | |
| CS4001CS | In distribution | |
| CS4002CS | In distribution | |
| CS4010-SCF | In distribution | |
| CS4001CF | In distribution | |
| CS4002C | In distribution | |
| CS4002CF | In distribution | |
| CS4003C | In distribution | |
| CS4000C | In distribution | |
| CS4001C | In distribution | |
| PRO-7140 | In distribution | |
| CS4000CF | In distribution | |
| CS4010 | In distribution | |
| CS4010-S | In distribution | |
| RC1000 | In distribution | |
| CS9005 | In distribution | |
| UC1000F | In distribution | |
| CS4001 | In distribution | |
| CS4003 | In distribution | |
| cs4010c | In distribution | |
| CS4002 | In distribution | |
| PRO-6140 | In distribution | |
| CS4000CS | In distribution | |
| RC1000F | In distribution | |
| CS4002S | In distribution | |
| UC1000 | Length 24 ft | In distribution |
| CS101 | In distribution | |
| CS4001S | In distribution | |
| csd4010 | In distribution | |
| CS9006 | In distribution | |
| PRO-7140RF | In distribution | |
| CS4000S | In distribution | |
| UC1000CFTC | In distribution | |
| CS4000 | In distribution | |
| cs9001 | 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 |
|---|---|
| K040726 | 2004-06-03 |
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.