SunMed
Large Adult Traditional Guedel Airway
84manufacturers in China registered for this device type
66catalogue numbers in this listing
2recalls on this code
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 | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | CAE |
| Device type | Airway, Oropharyngeal, Anesthesiology |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-21 |
| Record revised | 2024-12-31 (version 3) |
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 |
| Sizes | Length 3 to 11 cm; length 30 to 110 mm |
| Distribution end date | 2024-12-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-1521-01 | Length 60 mm | In distribution |
| 1-1504-50 | Length 5 cm | In distribution |
| 1-1506-70 | Length 7 cm | In distribution |
| 1-1521-06 | Length 110 mm | In distribution |
| 1-1508-60 | Length 6 cm | In distribution |
| 1-1505-90 | Length 9 cm | In distribution |
| 1-1521-03 | Length 80 mm | In distribution |
| 1-1508-70 | Length 7 cm | In distribution |
| 1-1500-99 | Length 10 cm | In distribution |
| 1-1503-09 | Length 9 cm | In distribution |
| 1-1505-60 | Length 6 cm | In distribution |
| 1-1500-60 | Length 6 cm | In distribution |
| 1-5010-20 | Length 40 mm | In distribution |
| 1-1505-40 | Length 4 cm | In distribution |
| 1-1506-60 | Length 6 cm | In distribution |
| 1-1506-50 | Length 5 cm | In distribution |
| 1-5010-98 | Length 3 cm | In distribution |
| 1-1505-70 | Length 7 cm | In distribution |
| 1-1508-00 | Length 40 mm | In distribution |
| 1-1521-20 | Length 40 mm | In distribution |
| 1-1508-40 | Length 4 cm | In distribution |
| 1-1504-80 | Length 8 cm | In distribution |
| 1-1504-99 | Length 10 cm | In distribution |
| 1-5010-01 | Length 60 mm | In distribution |
| 1-1500-80 | Length 8 cm | In distribution |
| 1-1505-80 | Length 8 cm | In distribution |
| 1-1504-00 | Length 40 mm | In distribution |
| 1-1504-90 | Length 9 cm | In distribution |
| 1-1500-90 | Length 9 cm | In distribution |
| 1-1521-30 | Length 30 mm | In distribution |
| 1-5010-02 | Length 70 mm | In distribution |
| 1-1504-11 | Length 11 cm | In distribution |
| 1-1508-80 | Length 8 cm | In distribution |
| 1-5010-10 | Length 50 mm | In distribution |
| 1-1521-10 | Length 50 mm | In distribution |
| 1-5010-03 | Length 80 mm | In distribution |
| 1-1500-50 | Length 5 cm | In distribution |
| 1-1505-50 | Length 5 cm | In distribution |
| 1-5010-30 | Length 30 mm | In distribution |
| 1-1508-90 | Length 9 cm | In distribution |
| 1-1504-60 | Length 6 cm | In distribution |
| 1-1501-70 | Length 7 cm | In distribution |
| 1-1506-11 | Length 11 cm | In distribution |
| 1-5010-04 | Length 90 mm | In distribution |
| 1-1500-70 | Length 7 cm | In distribution |
| 1-1504-70 | Length 7 cm | In distribution |
| 1-1506-40 | Length 4 cm | In distribution |
| 1-1521-02 | Length 70 mm | In distribution |
| 1-1506-99 | Length 10 cm | In distribution |
| 1-1501-00 | Length 50 mm | In distribution |
| 1-5010-05 | Length 100 mm | In distribution |
| 1-1505-11 | Length 11 cm | In distribution |
| 1-1506-80 | Length 8 cm | In distribution |
| 1-1508-99 | Length 10 cm | In distribution |
| 1-5010-06 | Length 110 mm | In distribution |
| 1-1521-04 | Length 90 mm | In distribution |
| 1-1505-99 | Length 10 cm | In distribution |
| 1-1501-80 | Length 8 cm | In distribution |
| 1-1506-90 | Length 9 cm | In distribution |
| 1-1503-10 | Length 10 cm | In distribution |
| 1-1501-50 | Length 5 cm | In distribution |
| 1-1521-05 | Length 100 mm | In distribution |
| 1-1504-40 | Length 4 cm | In distribution |
| 1-1508-50 | Length 5 cm | In distribution |
| 1-1501-60 | Length 6 cm | Withdrawn |
| 1-1501-99 | Length 10 cm | Withdrawn |
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 |
| 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 |
| Airway, Oropharyngeal, Anesthesiology | VBM Medizintechnik Gmbh | 26 |
Showing 12 of 347. All products under Airway, Oropharyngeal, Anesthesiology
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-12-22 | Class II | Under Investigation by firm | There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diamete | 43,290 (Eaches) |
| 2022-12-22 | Class II | Under Investigation by firm | There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diamete | 43,290 (Eaches) |
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.