Portex
208 catalogue numbers from 100/141/070, listed by ICU Medical, Inc, United States, under Tube, Tracheal (W/Wo Connector). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
208catalogue 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 | ICU Medical, Inc, 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K790312 |
| Record published | 2015-09-01 |
| Record revised | 2025-04-17 (version 7) |
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 |
| Packaging | Case of 10, box of 10, pallet of 12, box of 5, pallet of 10, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 100/141/070 | In distribution | ||
| L958 | In distribution | ||
| H4005S | In distribution | ||
| 100/111/020 | In distribution | ||
| H4001S | In distribution | ||
| 100/141/075 | In distribution | ||
| 100/136/060 | In distribution | ||
| 100/127/045 | In distribution | ||
| 008445 | In distribution | ||
| 100/110/075 | In distribution | ||
| 100/110/050 | In distribution | ||
| 513080 | In distribution | ||
| 100/179/050 | In distribution | ||
| 100/110/080 | In distribution | ||
| 100/110/090 | In distribution | ||
| 503060 | In distribution | ||
| 100/134/070 | In distribution | ||
| H4001PS | In distribution | ||
| 100/166/065 | In distribution | ||
| 100/136/065 | In distribution | ||
| 100/136/050 | In distribution | ||
| 100/132/030 | In distribution | ||
| H4003S | In distribution | ||
| 100/131/085 | In distribution | ||
| 100/166/090 | In distribution | ||
| 100/126/060 | In distribution | ||
| 505090 | In distribution | ||
| 100/127/095 | In distribution | ||
| 100/199/080 | In distribution | ||
| 100/110/085 | In distribution | ||
| 505060 | In distribution | ||
| 100/199/085 | In distribution | ||
| 100/113/050 | In distribution | ||
| 100/133/080 | In distribution | ||
| 100/132/065 | In distribution | ||
| 100/113/035 | In distribution | ||
| 100/105/060 | In distribution | ||
| 10025-05PS | 10 | In distribution | |
| 100/199/050 | In distribution | ||
| H4022PS | In distribution | ||
| 100/134/030 | In distribution | ||
| H4024S | In distribution | ||
| 100/126/035 | In distribution | ||
| 100/133/060 | In distribution | ||
| 100/111/030 | In distribution | ||
| 100/189/075 | In distribution | ||
| 100/136/055 | In distribution | ||
| 10045-05S | 10 | In distribution | |
| 100/127/090 | In distribution | ||
| 100/111/045 | In distribution | ||
| 100/136/080 | In distribution | ||
| 100/130/060 | In distribution | ||
| 100/133/065 | In distribution | ||
| 513090 | In distribution | ||
| 100/127/055 | In distribution | ||
| H4023PS | In distribution | ||
| 100/141/030 | In distribution | ||
| 100/130/070 | In distribution | ||
| 100/132/040 | In distribution | ||
| 100/179/075 | In distribution | ||
| 100/131/090 | In distribution | ||
| 100/110/095 | In distribution | ||
| 100/134/060 | In distribution | ||
| 10025-05S | 10 | In distribution | |
| 100/141/090 | In distribution | ||
| 100/131/065 | In distribution | ||
| 519000 | In distribution | ||
| 100/111/075 | In distribution | ||
| 100/111/025 | In distribution | ||
| 100/179/060 | In distribution | ||
| 100/132/050 | In distribution | ||
| 100/111/055 | In distribution | ||
| 503070 | In distribution | ||
| H4002S | In distribution | ||
| 100/141/055 | In distribution | ||
| 100/166/085 | In distribution | ||
| 100/189/070 | In distribution | ||
| 100/113/030 | In distribution | ||
| 100/111/085 | In distribution | ||
| 100/136/070 | In distribution | ||
| 100/134/065 | In distribution | ||
| 10030-05PS | 10 | In distribution | |
| 513070 | In distribution | ||
| 100/141/085 | In distribution | ||
| 100/199/055 | In distribution | ||
| 100/199/095 | In distribution | ||
| 503100 | In distribution | ||
| 100/141/050 | In distribution | ||
| 100/127/025 | In distribution | ||
| 100/141/060 | In distribution | ||
| 100/127/100 | In distribution | ||
| 100/131/075 | In distribution | ||
| 100/199/060 | In distribution | ||
| 100/105/025 | In distribution | ||
| 100/110/065 | In distribution | ||
| 10085-05S | 10 | In distribution | |
| 100/105/035 | In distribution | ||
| 100/130/065 | In distribution | ||
| 503080 | In distribution | ||
| 100/166/055 | In distribution | ||
| 100/134/035 | In distribution | ||
| 100/179/070 | In distribution | ||
| 100/131/080 | In distribution | ||
| L957 | In distribution | ||
| 100/126/045 | In distribution | ||
| 100/136/090 | In distribution | ||
| 100/199/090 | In distribution | ||
| H4022S | In distribution | ||
| 100/166/080 | In distribution | ||
| 10080-05S | 10 | In distribution | |
| 10075-05S | 10 | In distribution | |
| 10050-05S | 10 | In distribution | |
| 10035-05PS | 10 | In distribution | |
| 100/141/065 | In distribution | ||
| 100/131/060 | In distribution | ||
| 10070-05S | 10 | In distribution | |
| 10030-05S | 10 | In distribution | |
| 100/166/070 | In distribution | ||
| 100/127/085 | In distribution | ||
| 100/179/065 | In distribution | ||
| 100/166/100 | In distribution | ||
| 100/132/055 | In distribution | ||
| 10060-05S | 10 | In distribution | |
| 505080 | In distribution | ||
| 100/199/065 | In distribution | ||
| 100/189/085 | In distribution | ||
| 100/111/050 | In distribution | ||
| 100/127/075 | In distribution | ||
| 100/166/050 | In distribution | ||
| 100/111/040 | In distribution | ||
| 100/111/035 | In distribution | ||
| 100/141/080 | In distribution | ||
| 100/111/060 | In distribution | ||
| 100/110/055 | In distribution | ||
| 100/111/080 | In distribution | ||
| 100/179/055 | In distribution | ||
| 100/126/040 | In distribution | ||
| 100/136/085 | In distribution | ||
| H4004S | In distribution | ||
| 100/127/030 | In distribution | ||
| 100/127/080 | In distribution | ||
| 100/132/060 | In distribution | ||
| 100/113/045 | In distribution | ||
| 100/141/040 | In distribution | ||
| 505100 | In distribution | ||
| 513100 | In distribution | ||
| 503090 | In distribution | ||
| 100/127/065 | In distribution | ||
| 100/136/075 | In distribution | ||
| 100/126/030 | In distribution | ||
| 100/127/060 | In distribution | ||
| 100/126/025 | In distribution | ||
| 100/130/075 | In distribution | ||
| 100/132/045 | In distribution | ||
| 10035-05S | 10 | In distribution | |
| 100/111/070 | In distribution | ||
| H4026S | In distribution | ||
| 100/134/040 | In distribution | ||
| 100/133/075 | In distribution | ||
| 100/105/045 | In distribution | ||
| 100/105/055 | In distribution | ||
| H4023S | In distribution | ||
| 100/134/055 | In distribution | ||
| 100/126/050 | In distribution | ||
| H4021PS | In distribution | ||
| 100/141/045 | In distribution | ||
| 100/166/060 | In distribution | ||
| 100/110/070 | In distribution | ||
| 100/132/035 | In distribution | ||
| 100/134/050 | In distribution | ||
| 100/127/040 | In distribution | ||
| H4002PS | In distribution | ||
| 100/130/080 | In distribution | ||
| H4006S | In distribution | ||
| 100/166/075 | In distribution | ||
| 100/111/090 | In distribution | ||
| 100/126/055 | In distribution | ||
| 505070 | In distribution | ||
| H4021S | In distribution | ||
| 100/189/060 | In distribution | ||
| 100/127/070 | In distribution | ||
| H4003PS | In distribution | ||
| 100/105/040 | In distribution | ||
| 10040-05S | 10 | In distribution | |
| 100/112/030 | In distribution | ||
| H4025S | In distribution | ||
| 100/105/050 | In distribution | ||
| 100/133/070 | In distribution | ||
| 10090-05S | 10 | In distribution | |
| 100/111/065 | In distribution | ||
| 100/131/070 | In distribution | ||
| 100/141/025 | In distribution | ||
| 100/166/095 | In distribution | ||
| 100/113/040 | In distribution | ||
| 100/141/035 | In distribution | ||
| 513060 | In distribution | ||
| 100/199/075 | In distribution | ||
| 100/105/030 | In distribution | ||
| 100/127/050 | In distribution | ||
| 100/110/060 | In distribution | ||
| 100/189/065 | In distribution | ||
| 100/189/080 | In distribution | ||
| 100/199/070 | In distribution | ||
| 100/141/095 | In distribution | ||
| 100/134/045 | In distribution | ||
| 100/127/035 | In distribution | ||
| 100/132/070 | In distribution | ||
| 100/134/075 | 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 |
| 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 |
| Sheridan | Teleflex Medical LLC | 100 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-13 | Class I | Process change control | Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2014-07-07 | Class I | Process change control | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. | 135,518 (110,246 nationwide) | 2021-05-26 |
| Smiths Medical Asd, Inc. | 510(k) number | 2014-07-07 | Class I | Process change control | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. | 135,518 (110,246 nationwide) | 2021-05-26 |
| Smiths Medical Asd, Inc. | 510(k) number | 2014-07-07 | Class I | Process change control | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. | 135,518 (110,246 nationwide) | 2021-05-26 |
| Smiths Medical Asd, Inc. | 510(k) number | 2014-07-07 | Class I | Process change control | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. | 135,518 (110,246 nationwide) | 2021-05-26 |
| Smiths Medical Asd, Inc. | 510(k) number | 2014-04-10 | Class I | Packaging process control | One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm. | 100 devices | 2016-11-29 |
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.