Rusch
Green Non-Latex Robertazzi Nasopharyngeal Airway, Sterile
Who Else Makes It
Concentrated in Zhejiang (24), Guangdong (12), Jiangsu (8). 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 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| 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 |
| Guangzhou AMK Medical Equipment Co., Ltd. | Guang Zhou | Guangdong | Contract manufacturer | 10 |
| Guangzhou Shengwei Medical Devices Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 8 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 52. All 52 manufacturers in China registered for Airway, Nasopharyngeal
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BTQ |
| Device type | Airway, Nasopharyngeal |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2025-03-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, box of 10, box of 5, case of 266, case of 344, case of 50 |
| Sizes | Catheter gauge 12 to 36 Fr |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN042861 | In distribution | ||
| IPN918980 | In distribution | ||
| IPN042867 | In distribution | ||
| IPN042921 | In distribution | ||
| IPN042864 | In distribution | ||
| IPN042919 | In distribution | ||
| IPN042915 | In distribution | ||
| IPN042209 | In distribution | ||
| IPN042210 | In distribution | ||
| IPN042218 | In distribution | ||
| IPN042334 | Ch. 12 | 5 | In distribution |
| IPN042196 | In distribution | ||
| IPN042223 | In distribution | ||
| IPN042337 | Ch. 18 | 5 | In distribution |
| IPN042342 | Catheter Gauge 28 Fr | 5 | In distribution |
| IPN042914 | In distribution | ||
| IPN042207 | In distribution | ||
| IPN042226 | In distribution | ||
| IPN042219 | In distribution | ||
| IPN042216 | In distribution | ||
| IPN042918 | In distribution | ||
| IPN042201 | In distribution | ||
| IPN918962 | In distribution | ||
| IPN042925 | In distribution | ||
| IPN042205 | In distribution | ||
| IPN042228 | In distribution | ||
| IPN918954 | In distribution | ||
| IPN042340 | Ch. 24 | 5 | In distribution |
| IPN042343 | Catheter Gauge 30 Fr | 5 | In distribution |
| IPN042224 | In distribution | ||
| IPN042213 | In distribution | ||
| IPN042204 | In distribution | ||
| IPN042214 | In distribution | ||
| IPN042232 | In distribution | ||
| IPN042923 | In distribution | ||
| IPN042913 | In distribution | ||
| IPN042922 | In distribution | ||
| IPN042860 | In distribution | ||
| IPN042217 | In distribution | ||
| IPN042336 | Catheter Gauge 16 Fr | 5 | In distribution |
| IPN042222 | In distribution | ||
| IPN918964 | In distribution | ||
| IPN042341 | Ch. 26 | 5 | In distribution |
| IPN042862 | In distribution | ||
| IPN042212 | In distribution | ||
| IPN918958 | In distribution | ||
| IPN042220 | In distribution | ||
| IPN042211 | In distribution | ||
| IPN042335 | Ch. 14 | 5 | In distribution |
| IPN042227 | In distribution | ||
| IPN042230 | In distribution | ||
| IPN042202 | In distribution | ||
| IPN042863 | In distribution | ||
| IPN042197 | In distribution | ||
| IPN042203 | In distribution | ||
| IPN042200 | In distribution | ||
| IPN042344 | Ch. 32 | 5 | In distribution |
| IPN042345 | Catheter Gauge 34 Fr | 5 | In distribution |
| IPN042208 | In distribution | ||
| IPN042206 | In distribution | ||
| IPN042339 | Ch. 22 | 5 | In distribution |
| IPN918966 | In distribution | ||
| IPN042199 | In distribution | ||
| IPN042195 | In distribution | ||
| IPN042924 | In distribution | ||
| IPN042920 | In distribution | ||
| IPN042346 | Catheter Gauge 36 Fr | 5 | In distribution |
| IPN042868 | In distribution | ||
| IPN042225 | In distribution | ||
| IPN042198 | In distribution | ||
| IPN042229 | In distribution | ||
| IPN042865 | In distribution | ||
| IPN042338 | Catheter Gauge 20 Fr | 5 | In distribution |
| IPN042917 | In distribution | ||
| IPN042221 | In distribution | ||
| IPN042866 | In distribution | ||
| IPN042916 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaplex | Bound Tree Medical, LLC | 67 |
| SunMed | SunMed Group Holdings, LLC | 62 |
| Nasopharyngeal airway | Well Lead Medical Co., Ltd. | 40 |
| McKesson | Mckesson Medical-Surgical Inc. | 38 |
| Cardinal Health | Cardinal Health 200, LLC | 26 |
| SourceMark | Sourcemark, LLC. | 25 |
| Medis | Tianjin Medis Medical Device Co., Ltd. | 24 |
| MedSource Airway Devices | Medsource International, LLC | 22 |
| Kenorex | Kentron Healthcare, Inc. | 13 |
| Kentex | Kentron Healthcare, Inc. | 13 |
| Shiley | Covidien LP | 12 |
| Nasopharyngeal Airway | Dynarex Corp. | 8 |
Showing 12 of 78. All products under Airway, Nasopharyngeal
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|---|
| 2017-01-13 | Class II | Unknown/Undetermined by firm | Labeling error | 7,600 eaches | 2025-02-10 |
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.