O-Two
O-Two Guedel Airway is an oropharyngeal airway insert into a patient’s pharynx through the mouth to provide a patent airway. The Air Way Kit 01AM3000 contains eight sizes of air ways: 40MM,…
O-Two Guedel Airway is an oropharyngeal airway insert into a patient’s pharynx through the mouth to provide a patent airway. The Air Way Kit 01AM3000 contains eight sizes of air ways: 40MM, 50MM 60MM, 70MM, 80MM, 90MM, 100MM and 110MM. The bit block is rigid and identified with color coding. The smooth surface and rounded tip can improve patient comfort. O-Two Guedel Airway is manufactured with 100% Polyethylene (PE) which is latex free and for single use only.
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 | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | CAE |
| Device type | Airway, Oropharyngeal, Anesthesiology |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-05-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 60 °C |
| Packaging | Pack of 50 |
| Sizes | Length 40 to 110 mm; weight 190 g; length 7 in; width 4.5 in; height 2 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01AM3005U | Length 80 mm | In distribution |
| 01AM3008U | Length 110 mm | In distribution |
| 01AM3007U | Length 100 mm | In distribution |
| 01AM3002U | Length 50 mm | In distribution |
| 01AM3001U | Length 40 mm | In distribution |
| 01AM3004U | Length 70 mm | In distribution |
| 01AM3003U | Length 60 mm | In distribution |
| 01AM3000 | Weight 190 g | In distribution |
| 01AM3006U | Length 90 mm | 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
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.