Merlyn EndoTube
6.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip
9manufacturers in China registered for this device type
50catalogue numbers in this listing
1510(k) clearance
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 | Merlyn Associates, Inc., United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Complaint-file establishment |
| 510(k) | K042683 |
| Record published | 2016-06-01 |
| 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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 32 to 120 °F |
| Packaging | Inner carton of 10, inner cartion of 10 |
| Sizes | Lumen/inner diameter 3 to 8.5 mm; length 3.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Preformed Nasal 440035 | Lumen/Inner Diameter 3.5 mm | In distribution |
| Preformed Oral 420040 | Lumen/Inner Diameter 4.0 mm | In distribution |
| Preformed Oral 420045 | Lumen/Inner Diameter 4.5 mm | In distribution |
| Oral/Nasal 401060 | Lumen/Inner Diameter 6.0 mm | In distribution |
| Oral/Nasal 401045 | Lumen/Inner Diameter 4.5 mm | In distribution |
| Oral/Nasal 401065 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Oral/Nasal 401080 | Lumen/Inner Diameter 8.0 mm | In distribution |
| Preformed Nasal 440055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Preformed Nasal 440050 | Lumen/Inner Diameter 5.0 mm | In distribution |
| Oral/Nasal 401030 | Lumen/Inner Diameter 3.0 mm | In distribution |
| Oral/Nasal 411040 | Lumen/Inner Diameter 5.0 mm | In distribution |
| Oral/Nasal 401070 | Lumen/Inner Diameter 7.0 mm | In distribution |
| Oral/Nasal 411035 | Lumen/Inner Diameter 3.5 mm | In distribution |
| Preformed Nasal 440045 | Lumen/Inner Diameter 4.5 mm | In distribution |
| Preformed Oral 431040 | Lumen/Inner Diameter 4.0 mm | In distribution |
| Oral/Nasal 401050 | Lumen/Inner Diameter 5.0 mm | In distribution |
| Preformed Nasal 440060 | Lumen/Inner Diameter 6.0 mm | In distribution |
| Preformed Nasal 451035 | Lumen/Inner Diameter 3.5 mm | In distribution |
| Oral/Nasal 411055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Oral/Nasal 401075 | Lumen/Inner Diameter 7.5 mm | In distribution |
| Oral/Nasal 401040 | Lumen/Inner Diameter 4.0 mm | In distribution |
| Preformed Oral 420055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Preformed Nasal 440065 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Oral/Nasal 401085 | Lumen/Inner Diameter 8.5 mm | In distribution |
| Preformed Oral 420035 | Lumen/Inner Diameter 3.5 mm | In distribution |
| Preformed Oral 431045 | Lumen/Inner Diameter 4.5 mm | In distribution |
| Preformed Nasal 451055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Preformed Nasal 451050 | Lumen/Inner Diameter 5.0 mm | In distribution |
| Preformed Oral 431035 | Length 3.5 mm | In distribution |
| Oral/Nasal 411045 | Lumen/Inner Diameter 4.5 mm | In distribution |
| Preformed Nasal 451060 | Lumen/Inner Diameter 6.0 mm | In distribution |
| Preformed Oral 420065 | Lumen/Inner Diameter 6.5 mm | In distribution |
| Oral/Nasal 401035 | Lumen/Inner Diameter 3.5 mm | In distribution |
| Preformed Oral 420050 | Lumen/Inner Diameter 5.0 mm | In distribution |
| Preformed Nasal 451030 | Lumen/Inner Diameter 3.0 mm | In distribution |
| Preformed Oral 431050 | Lumen/Inner Diameter 5.0 mm | In distribution |
| Oral/Nasal 411060 | Lumen/Inner Diameter 6.0 mm | In distribution |
| Preformed Nasal 451040 | Lumen/Inner Diameter 4.0 mm | In distribution |
| Oral/Nasal 401055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Oral/Nasal 411030 | Lumen/Inner Diameter 3.0 mm | In distribution |
| Preformed Nasal 440070 | Lumen/Inner Diameter 7.0 mm | In distribution |
| Preformed Oral 431060 | Lumen/Inner Diameter 6.0 mm | In distribution |
| Preformed Nasal 440040 | Lumen/Inner Diameter 4.0 mm | In distribution |
| Preformed Oral 420070 | Lumen/Inner Diameter 7.0 mm | In distribution |
| Preformed Oral 420080 | Lumen/Inner Diameter 8.0 mm | In distribution |
| Preformed Nasal 451045 | Lumen/Inner Diameter 4.5 mm | In distribution |
| Preformed Oral 431030 | Lumen/Inner Diameter 3.0 mm | In distribution |
| Preformed Oral 431055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| Preformed Oral 420060 | Lumen/Inner Diameter 6.0 mm | In distribution |
| Preformed Oral 420075 | Lumen/Inner Diameter 7.5 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 |
| Sunmed | SunMed Group Holdings, LLC | 112 |
| Forsure | Forsure Medical Products LLC. | 101 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K031794 | 2004-03-12 |
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.