Venticaire Lite
Adult Venturi Fixed Concentration Mask Set with 24% 28% 31% 35% 40% Barrels + 2.1m Oxygen Tubing
46manufacturers in China registered for this device type
91catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (22), Guangdong (7), Jiangsu (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Showing 12 of 46. All 46 manufacturers in China registered for Mask, Oxygen, Low Concentration, Venturi
Record
| Listed by | Flexicare Medical Ltd., United Kingdom |
|---|---|
| FDA product code | BYF |
| Device type | Mask, Oxygen, Low Concentration, Venturi |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5600 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 033-10-050TU | In distribution | |
| 033-10-044TU | In distribution | |
| 033-10-051CTU | In distribution | |
| 033-10-025U | In distribution | |
| 033-10-048T/1U | In distribution | |
| 033-10-040U | In distribution | |
| 033-10-040TU | In distribution | |
| 033-10-044U | In distribution | |
| 033-10-043CT/1U | In distribution | |
| 033-10-054TU | In distribution | |
| 033-10-044CU | In distribution | |
| 033-10-042U | In distribution | |
| 033-10-027U | In distribution | |
| 033-10-040T/1U | In distribution | |
| 033-10-059CTU | In distribution | |
| 033-10-052CTU | In distribution | |
| 033-10-041CTU | In distribution | |
| 033-10-040CTU | In distribution | |
| 033-10-051U | In distribution | |
| 033-10-054U | In distribution | |
| 033-10-048TU | In distribution | |
| 033-10-049TU | In distribution | |
| 033-10-053CTU | In distribution | |
| 033-10-054CT/1U | In distribution | |
| 033-10-042CU | In distribution | |
| 033-10-050CT/1U | In distribution | |
| 033-10-040CU | In distribution | |
| 033-10-044CTU | In distribution | |
| 033-10-054CU | In distribution | |
| 033-10-041CU | In distribution | |
| 033-10-024U | In distribution | |
| 033-10-058CU | In distribution | |
| 033-10-059/1U | In distribution | |
| 033-10-049CTU | In distribution | |
| 033-10-028U | In distribution | |
| 033-10-044T/1U | In distribution | |
| 033-10-041CT/1U | In distribution | |
| 033-10-049T/1U | In distribution | |
| 033-10-054T/1U | In distribution | |
| 033-10-055TU | In distribution | |
| 033-10-059TU | In distribution | |
| 033-10-052CU | In distribution | |
| 033-10-043T/1U | In distribution | |
| 033-10-058U | In distribution | |
| 033-10-048U | In distribution | |
| 033-10-006U | In distribution | |
| 033-10-053U | In distribution | |
| 033-10-051CU | In distribution | |
| 033-10-054CTU | In distribution | |
| 033-10-050CTU | In distribution | |
| 033-10-043TU | In distribution | |
| 033-10-053TU | In distribution | |
| 033-10-049U | In distribution | |
| 033-10-080/1U | In distribution | |
| 033-10-051TU | In distribution | |
| 033-10-041T/1U | In distribution | |
| 033-10-058T/1U | In distribution | |
| 033-10-026U | In distribution | |
| 033-10-028PU | In distribution | |
| 033-10-052U | In distribution | |
| 033-10-051T/1U | In distribution | |
| 033-10-052TU | In distribution | |
| 033-10-043U | In distribution | |
| 033-10-043CTU | In distribution | |
| 033-10-042CTU | In distribution | |
| 033-10-048CU | In distribution | |
| 033-10-048CT/1U | In distribution | |
| 033-10-028PT/1U | In distribution | |
| 033-10-041U | In distribution | |
| 033-10-050U | In distribution | |
| 033-10-050CU | In distribution | |
| 033-10-010U | In distribution | |
| 033-10-050T/1U | In distribution | |
| 033-10-028PTU | In distribution | |
| 033-10-043CU | In distribution | |
| 033-10-049CT/1U | In distribution | |
| 033-10-053CT/1U | In distribution | |
| 033-10-042CT/1U | In distribution | |
| 033-10-044CT/1U | In distribution | |
| 033-10-053CU | In distribution | |
| 033-10-042T/1U | In distribution | |
| 033-10-059CT/1U | In distribution | |
| 033-10-048CTU | In distribution | |
| 033-10-058CT/1U | In distribution | |
| 033-10-053T/1U | In distribution | |
| 033-10-041TU | In distribution | |
| 033-10-051CT/1U | In distribution | |
| 033-10-042TU | In distribution | |
| 033-10-028T/1U | In distribution | |
| 033-10-028TU | In distribution | |
| 033-10-058CTU | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 21 |
| Mask, Oxygen, Low Concentration, Venturi | Salter Labs | 16 |
| CPAP Kit | Sunset Healthcare Solutions, Inc. | 9 |
| Pegasus | Pegasus Research Corp. | 6 |
| Medline | Medline Industries, Inc. | 4 |
| Hanwell | Ningbo Hanyue Medical Technology Co., Ltd. | 3 |
| Lightning X Products,Inc | Wuxi Emsrun Technology Co., Ltd. | 2 |
| Aerosol & Nebs | Sunset Healthcare Solutions, Inc. | 2 |
| Venturi Mask Adult W/6 Diluters, W/7FT Tubing, 6 Inch Corrugate Tube | Besmed Health Business Corporation | 2 |
| Resp-O2 Venturi Select A Vent Elongated Mask | Dynarex Corp. | 2 |
| Resp-O2 Venturi Adjustable Dial Elongated Mask | Dynarex Corp. | 2 |
| Rhino Rescue | Wuxi Emsrun Technology Co., Ltd. | 2 |
Showing 12 of 68. All products under Mask, Oxygen, Low Concentration, Venturi
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K951652 | 1995-04-27 |
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.