Oral Airways, Disposable
Oral Airways, Individually Bagged, Disposable, X-Large, 110 mm, Orange
84manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (30), Guangdong (18), Jiangsu (12). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
Showing 12 of 84. All 84 manufacturers in China registered for Airway, Oropharyngeal, Anesthesiology
Record
| Listed by | Dynarex Corp., United States |
|---|---|
| FDA product code | CAE |
| Device type | Airway, Oropharyngeal, Anesthesiology |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-09 |
| Record revised | 2024-10-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Packaging | Pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4727 | In distribution | ||
| 4737 | In distribution | ||
| 4767 | In distribution | ||
| 4715 | 100 | In distribution | |
| 4745 | 100 | In distribution | |
| 4765 | 100 | In distribution | |
| 4747 | In distribution | ||
| 4717 | In distribution | ||
| 4757 | In distribution | ||
| 4735 | 100 | In distribution | |
| 4725 | 100 | In distribution | |
| 4755 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LMA Airway Management | Teleflex Medical LLC | 444 |
| Rusch | Teleflex Medical LLC | 129 |
| SourceMark | Sourcemark, LLC. | 94 |
| Curaplex | Bound Tree Medical, LLC | 86 |
| Hudson RCI | Teleflex Medical LLC | 83 |
| SunMed | SunMed Group Holdings, LLC | 66 |
| Medline | Medline Industries, Inc. | 59 |
| LMA | Teleflex Medical LLC | 50 |
| MediChoice | Owens & Minor Distribution, Inc. | 33 |
| ADC® | American Diagnostic Corp. | 32 |
| Air-Q3® | Airlife, Inc. | 32 |
| Compower | Xiamen Compower Medical Tech. Co., Ltd. | 29 |
Showing 12 of 347. All products under Airway, Oropharyngeal, Anesthesiology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K891586 | 1989-05-11 |
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.