Mask, Oxygen, Low Concentration, Venturi
Percent-O2-Lock®/Trach Tee System with 7’ (2.1 m) supply tube The Percent-O2-Lock® Mask is an air-entrainment oxygen valve.
46manufacturers in China registered for this device type
16catalogue 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 | Salter Labs, United States |
|---|---|
| FDA product code | BYF |
| Device type | Mask, Oxygen, Low Concentration, Venturi |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5600 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K772127 |
| Record published | 2016-11-30 |
| Record revised | 2024-12-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -40 to 60 °C; Handling environment temperature 5 to 40 °C |
| Packaging | Pack of 50, pack of 25 |
| Distribution end date | 2026-03-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8150-7 | Adult | In distribution |
| 8058-7 | In distribution | |
| 8121TG-7 | pediatric | In distribution |
| M128528-0 | In distribution | |
| 8150TG-7 | Adult | In distribution |
| 8121-7 | pediatric | In distribution |
| 8057-0 | In distribution | |
| 8054-7 | In distribution | |
| M124787-0 | In distribution | |
| 8050-7 | Adult | In distribution |
| 8120TG-7 | pediatric | In distribution |
| 8059-7 | In distribution | |
| 8150TLC-7 | Adult | In distribution |
| M124753-0 | In distribution | |
| 8056-0 | In distribution | |
| 8120-7 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Venticaire Lite | Flexicare Medical Ltd. | 91 |
| Hudson RCI | Teleflex Medical LLC | 21 |
| 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 |
|---|---|
| K772127 | 1978-01-03 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | 510(k) number | 2011-03-25 | Not classified | Equipment maintenance | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. | 800 all varieties | 2011-10-26 |
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.