Parker Flex-Tip
Endotracheal Tube, DEHP-free, Low Pressure, Polyurethane Cuff, no Murphy eyes, (PTCL), Parker, 3.5mm
9manufacturers in China registered for this device type
164catalogue 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 | Salter Labs, United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-27 |
| 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 |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 55 °C |
| Packaging | Case of 10, box of 10, box of 5 |
| Sizes | Lumen/inner diameter 2.5 to 9.5 mm; lumen/inner diameter 5 to 8 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H-PFNC-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFNU-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFTVVC-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFTVVC-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFEC-80 | Lumen/Inner Diameter 8.0 cm | In distribution |
| H-PTCL-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PFHV-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PMLT-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFTVPU-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFHV-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PFUO-25 | Lumen/Inner Diameter 2.5 mm | In distribution |
| H-PFLP-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFOU-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PMLT-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFOL-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PFTVPU-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFNU-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PMLT-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFNC-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFLP-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFHV-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PTCL-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFOU-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFHV-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFOC-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PFOC-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFTVVC-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFUO-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PTCY-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFTVPU-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFHV-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFOU-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFUO-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFNC-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PTCY-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFLP-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PFST-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFOC-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFNC-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFNC-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFTVVC-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFNC-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFOC-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PFRU-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PFNU-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFST-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFOU-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFOU-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PFUO-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFUO-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PTCY-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PTCY-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFNU-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFLP-95 | Lumen/Inner Diameter 9.5 mm | In distribution |
| H-PFOL-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PFUO-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFOU-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFTVPU-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFOL-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFTVPU-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFLP-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFOU-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFOU-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PFHV-95 | Lumen/Inner Diameter 9.5 mm | In distribution |
| H-PFUO-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFNU-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PFUO-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFLP-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFUO-95 | Lumen/Inner Diameter 9.5 mm | In distribution |
| H-PFOU-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFLP-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFEC-50 | Lumen/Inner Diameter 5.0 cm | In distribution |
| H-PFTVVC-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFLP-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFOU-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFST-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFRU-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PFHV-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PTCL-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFST-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFST-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFUO-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PFNU-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFLP-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PFRU-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFOC-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PFHV-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFTVVC-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFOC-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFNC-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFOL-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFST-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFOC-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFST-95 | Lumen/Inner Diameter 9.5 mm | In distribution |
| H-PFNU-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFOL-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PFLP-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PTCL-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PTCL-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFHV-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PTCY-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PTCY-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFNU-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PTCL-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFUO-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PTCL-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFRC-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFLP-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFNC-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFHV-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFOC-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFNU-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFST-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFRC-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFOC-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PTCY-95 | Lumen/Inner Diameter 9.5 mm | In distribution |
| H-PTCY-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFNU-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFEC-60 | Lumen/Inner Diameter 6.0 cm | In distribution |
| H-PTCL-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PFOL-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFOC-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFOU-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFOU-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFNC-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFST-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFNC-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFOC-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFUO-35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| H-PFOC-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFLP-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFHV-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFRC-95 | Lumen/Inner Diameter 9.5 mm | In distribution |
| H-PFEC-70 | Lumen/Inner Diameter 7.0 cm | In distribution |
| H-PFST-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFRC-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFRC-55 | Lumen/Inner Diameter 5.5 mm | In distribution |
| H-PFRC-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFTVPU-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFLP-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFOU-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PFHV-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFST-90 | Lumen/Inner Diameter 9.0 mm | In distribution |
| H-PFOC-80 | Lumen/Inner Diameter 8.0 mm | In distribution |
| H-PFTVPU-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFNC-65 | Lumen/Inner Diameter 6.5 mm | In distribution |
| H-PFUO-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFLP-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFRC-85 | Lumen/Inner Diameter 8.5 mm | In distribution |
| H-PFNU-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PFUO-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFST-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PFHV-70 | Lumen/Inner Diameter 7.0 mm | In distribution |
| H-PFRU-45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| H-PFNU-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFTVVC-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PTCL-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFHV-30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| H-PFNU-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFRC-75 | Lumen/Inner Diameter 7.5 mm | In distribution |
| H-PFRC-60 | Lumen/Inner Diameter 6.0 mm | In distribution |
| H-PFRU-40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| H-PFOL-50 | Lumen/Inner Diameter 5.0 mm | In distribution |
| H-PFUO-45 | Lumen/Inner Diameter 4.5 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 | 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 |
| Sheridan | Teleflex Medical LLC | 100 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190878 | 2020-01-10 |
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.