Sunmed
PREFORMED NASAL UNCUFFED E/T TUBE 4.5mm 18FR
9manufacturers in China registered for this device type
112catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 4 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 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Qingdao Traworks Co., Ltd. | Qingdao | Shandong | Exporter | 7 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Chilecom Medical Devices Co Ltd | Xiangtan | Hunan | Manufacturer | 5 |
Record
| Listed by | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K042683 |
| Record published | 2016-11-01 |
| Record revised | 2020-06-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature up to 49 °C; Special storage condition: Do not get wet. Keep out of direct sunlight. |
| Packaging | Box of 10, 800-433-2797 of 10 |
| Sizes | Outer diameter 2.67 to 13.67 mm; length 5.5 to 330 mm; lumen/inner diameter 2 to 34 mm; height 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-7321-65 | Length 210 mm | In distribution |
| 1-7321-70 | Length 230 mm | In distribution |
| 1-7393-70 | Length 300 mm | In distribution |
| 1-7321-85 | Length 260 mm | In distribution |
| 1-7333-40 | Length 210 mm | In distribution |
| 1-7363-65 | Outer Diameter 8.67 mm | In distribution |
| 1-7343-30 | Length 165 mm | In distribution |
| 1-7343-75 | Length 315 mm | In distribution |
| 1-7321-60 | Length 190 mm | In distribution |
| 1-7321-45 | Length 150 mm | In distribution |
| 1-7321-40 | Length 140 mm | In distribution |
| 1-7343-35 | Length 185 mm | In distribution |
| 1-7330-50 | Length 245 mm | In distribution |
| 1-7371-37 | Outer Diameter 12.33 mm | In distribution |
| 1-7333-10 | Length 330 mm | In distribution |
| 1-7333-70 | Length 310 mm | In distribution |
| 1-7363-75 | Length 315 mm | In distribution |
| 1-7321-80 | Outer Diameter 10.65 mm | In distribution |
| 1-7393-85 | Length 320 mm | In distribution |
| 1-7320-45 | Length 150 mm | In distribution |
| 1-7321-90 | Length 270 mm | In distribution |
| 1-7343-95 | Length 330 mm | In distribution |
| 1-7393-90 | Length 320 mm | In distribution |
| 1-7322-45 | Length 220 mm | In distribution |
| 1-7321-50 | Length 160 mm | In distribution |
| 1-7330-40 | Length 210 mm | In distribution |
| 1-7370-41 | Outer Diameter 13.67 mm | In distribution |
| 1-7333-85 | Length 330 mm | In distribution |
| 1-7330-55 | Length 275 mm | In distribution |
| 1-7333-75 | Length 315 mm | In distribution |
| 1-7323-40 | Length 200 mm | In distribution |
| 1-7393-65 | Length 290 mm | In distribution |
| 1-7323-75 | Length 310 mm | In distribution |
| 1-7322-40 | Height 200 mm | In distribution |
| 1-7323-80 | Length 320 mm | In distribution |
| 1-7363-10 | Length 330 mm | In distribution |
| 1-7333-80 | Length 330 mm | In distribution |
| 1-7371-41 | Outer Diameter 13.67 mm | In distribution |
| 1-7343-70 | Length 310 mm | In distribution |
| 1-7322-50 | Length 240 mm | In distribution |
| 1-7320-50 | Length 160 mm | In distribution |
| 1-7343-55 | Length 275 mm | In distribution |
| 1-7393-10 | Length 320 mm | In distribution |
| 1-7330-25 | Length 145 mm | In distribution |
| 1-7393-50 | Length 240 mm | In distribution |
| 1-7393-80 | Length 320 mm | In distribution |
| 1-7322-30 | Length 160 mm | In distribution |
| 1-7322-55 | Length 270 mm | In distribution |
| 1-7323-45 | Length 220 mm | In distribution |
| 1-7323-55 | Length 270 mm | In distribution |
| 1-7363-45 | Length 225 mm | In distribution |
| 1-7320-55 | Length 170 mm | In distribution |
| 1-7343-60 | Length 285 mm | In distribution |
| 1-7363-90 | Length 330 mm | In distribution |
| 1-7333-90 | Length 330 mm | In distribution |
| 1-7390-35 | Length 180 mm | In distribution |
| 1-7393-75 | Length 310 mm | In distribution |
| 1-7343-90 | Length 330 mm | In distribution |
| 1-7323-65 | Length 290 mm | In distribution |
| 1-7390-40 | Length 200 mm | In distribution |
| 1-7321-75 | Length 240 mm | In distribution |
| 1-7343-50 | Length 245 mm | In distribution |
| 1-7363-85 | Length 330 mm | In distribution |
| 1-7333-30 | Length 165 mm | In distribution |
| 1-7320-35 | Length 130 mm | In distribution |
| 1-7393-95 | Length 320 mm | In distribution |
| 1-7330-45 | Length 225 mm | In distribution |
| 1-7363-70 | Length 310 mm | In distribution |
| 1-7330-30 | Length 165 mm | In distribution |
| 1-7320-40 | Length 140 mm | In distribution |
| 1-7333-45 | Length 225 mm | In distribution |
| 1-7363-55 | Length 275 mm | In distribution |
| 1-7322-35 | Length 180 mm | In distribution |
| 1-7343-45 | Length 225 mm | In distribution |
| 1-7333-35 | Length 185 mm | In distribution |
| 1-7371-35 | Outer Diameter 11.67 mm | In distribution |
| 1-7333-60 | Length 285 mm | In distribution |
| 1-7390-50 | Length 240 mm | In distribution |
| 1-7370-37 | Outer Diameter 12.33 mm | In distribution |
| 1-7330-65 | Length 295 mm | In distribution |
| 1-7393-60 | Length 280 mm | In distribution |
| 1-7370-39 | Outer Diameter 13 mm | In distribution |
| 1-7390-45 | Length 220 mm | In distribution |
| 1-7343-10 | Length 330 mm | In distribution |
| 1-7371-39 | Outer Diameter 13 mm | In distribution |
| 1-7333-65 | Length 295 mm | In distribution |
| 1-7330-20 | Length 140 mm | In distribution |
| 1-7370-35 | Outer Diameter 11.67 mm | In distribution |
| 1-7343-85 | Outer Diameter 11.33 mm | In distribution |
| 1-7323-70 | Length 300 mm | In distribution |
| 1-7333-50 | Length 245 mm | In distribution |
| 1-7333-25 | Length 150 mm | In distribution |
| 1-7320-30 | Length 120 mm | In distribution |
| 1-7323-50 | Length 240 mm | In distribution |
| 1-7363-80 | Length 330 mm | In distribution |
| 1-7333-55 | Length 275 mm | In distribution |
| 1-7330-35 | Length 185 mm | In distribution |
| 1-7330-70 | Length 310 mm | In distribution |
| 1-7363-40 | Length 210 mm | In distribution |
| 1-7363-50 | Length 245 mm | In distribution |
| 1-7343-65 | Length 295 mm | In distribution |
| 1-7321-55 | Length 170 mm | In distribution |
| 1-7390-30 | Length 160 mm | In distribution |
| 1-7323-60 | Length 280 mm | In distribution |
| 1-7363-35 | Length 185 mm | In distribution |
| 1-7330-60 | Length 285 mm | In distribution |
| 1-7333-95 | Outer Diameter 12.67 mm | In distribution |
| 1-7363-60 | Length 285 mm | In distribution |
| 1-7343-40 | Length 210 mm | In distribution |
| 1-7363-95 | Length 330 mm | In distribution |
| 1-7393-55 | Length 270 mm | In distribution |
| 1-7343-80 | Length 330 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 301 |
| Shiley | Covidien LP | 295 |
| Mallinckrodt | Covidien LP | 258 |
| Hudson RCI | Teleflex Medical LLC | 241 |
| Portex | ICU Medical, Inc | 208 |
| Parker Flex-Tip | Salter Labs | 164 |
| Parker | Salter Labs | 157 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| SourceMark | Sourcemark, LLC. | 148 |
| Montgomery® Safe-T-Tube™ | Boston Medical Products, Inc. | 144 |
| Forsure | Forsure Medical Products LLC. | 101 |
| Sheridan | Teleflex Medical LLC | 100 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
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 |
|---|---|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | 510(k) number | 2026-07-31 | Not classified | Process control | The 6Fr suction catheter could not pass through the samples smoothly. | 27200 |
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.