Portex
380 catalogue numbers from 100/826/100, listed by ICU Medical, Inc, United States, under Tube, Tracheostomy (W/Wo Connector). 1 manufacturer in China is registered for this product code.
1manufacturer
380catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K903730 |
| Record published | 2015-09-01 |
| Record revised | 2025-06-09 (version 7) |
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 |
| Packaging | Box, carton of 10, case of 10, box of 10, carton of 30, case |
| Distribution end date | 2015-10-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 100/826/100 | In distribution | ||
| 101/812/060CZ | In distribution | ||
| 101/540/080 | In distribution | ||
| 100/858/100 | In distribution | ||
| 100/825/080 | In distribution | ||
| 502080 | In distribution | ||
| 100/870/070CZ | In distribution | ||
| 101/811/075CZ | In distribution | ||
| 101/813/090 | In distribution | ||
| 101/870/070 | In distribution | ||
| 101/811/085CZ | In distribution | ||
| 100/858/080 | In distribution | ||
| 100/897/090CZ | In distribution | ||
| 100/818/060 | In distribution | ||
| 100/825/085 | In distribution | ||
| 101/810/080CZ | In distribution | ||
| 100/816/100 | In distribution | ||
| 100/782/080 | In distribution | ||
| W1136 | In distribution | ||
| 100/815/060 | In distribution | ||
| 526070 | In distribution | ||
| 100/816/090 | In distribution | ||
| 100/815/085 | In distribution | ||
| 100/815/100 | In distribution | ||
| 101/850/075CZ | In distribution | ||
| 100/815/080 | In distribution | ||
| 100/817/100 | In distribution | ||
| 101/802/090CZ | In distribution | ||
| 101/813/090CZ | In distribution | ||
| 101/802/080 | In distribution | ||
| 101/812/100 | In distribution | ||
| 100/897/080CZ | In distribution | ||
| 100/870/100 | In distribution | ||
| 504100 | In distribution | ||
| 100/870/085CZ | In distribution | ||
| 101/870/075 | In distribution | ||
| 101/851/080CZ | In distribution | ||
| 100/885/085 | In distribution | ||
| 101/875/100 | In distribution | ||
| 100/541/090 | In distribution | ||
| 100/781/090 | In distribution | ||
| 100/899/090 | In distribution | ||
| 100/825/100 | In distribution | ||
| 6952 | In distribution | ||
| 101/860/060 | In distribution | ||
| 101/812/060 | In distribution | ||
| 100/781/100 | In distribution | ||
| 101/810/100 | In distribution | ||
| 101/810/090 | In distribution | ||
| 100/597/080CZ | In distribution | ||
| W1119 | In distribution | ||
| 512070 | In distribution | ||
| 101/850/100CZ | In distribution | ||
| 100/890/090 | In distribution | ||
| 101/543/070 | In distribution | ||
| 101/860/090CZ | In distribution | ||
| 101/811/070 | In distribution | ||
| 101/813/075CZ | In distribution | ||
| 100/818/090 | In distribution | ||
| 100/890/070CZ | In distribution | ||
| 100/825/070 | In distribution | ||
| 101/858/090 | In distribution | ||
| 100/597/090 | In distribution | ||
| 100/783/070 | In distribution | ||
| 100/597/090CZ | In distribution | ||
| 100/856/090 | In distribution | ||
| 101/856/085 | In distribution | ||
| 100/855/000 | 20 | In distribution | |
| 101/802/100CZ | In distribution | ||
| 100/784/090 | In distribution | ||
| 101/860/080 | In distribution | ||
| 100/541/080CZ | In distribution | ||
| 101/815/080 | In distribution | ||
| 100/541/090CZ | In distribution | ||
| 100/816/080 | In distribution | ||
| 100/870/090 | In distribution | ||
| 101/858/070 | In distribution | ||
| 101/813/085 | In distribution | ||
| 101/851/075 | In distribution | ||
| 101/850/090CZ | In distribution | ||
| 101/818/100 | In distribution | ||
| 100/870/060 | In distribution | ||
| 101/810/060CZ | In distribution | ||
| 101/851/070CZ | In distribution | ||
| 100/875/075 | In distribution | ||
| 101/802/100 | In distribution | ||
| 100/885/060 | In distribution | ||
| 100/826/060 | In distribution | ||
| 100/858/070 | In distribution | ||
| 100/885/075 | In distribution | ||
| 101/813/085CZ | In distribution | ||
| 101/870/060 | In distribution | ||
| 101/812/070 | In distribution | ||
| 502090 | In distribution | ||
| 100/897/070 | In distribution | ||
| 101/813/060 | In distribution | ||
| 504060 | In distribution | ||
| 100/826/090 | In distribution | ||
| 100/858/060 | In distribution | ||
| 101/850/070CZ | In distribution | ||
| 101/800/075CZ | In distribution | ||
| 502060 | In distribution | ||
| 101/595/070 | In distribution | ||
| 101/813/070 | In distribution | ||
| 101/802/080CZ | In distribution | ||
| 101/870/100CZ | In distribution | ||
| 101/875/060 | In distribution | ||
| 101/812/085 | In distribution | ||
| 100/816/060 | In distribution | ||
| 101/561/080 | In distribution | ||
| 512100 | In distribution | ||
| 101/860/075 | In distribution | ||
| 100/818/070 | In distribution | ||
| 101/802/085CZ | In distribution | ||
| 100/597/070 | In distribution | ||
| 101/543/090 | In distribution | ||
| 100/885/080 | In distribution | ||
| 100/597/070CZ | In distribution | ||
| 101/818/080 | In distribution | ||
| W1120 | In distribution | ||
| 100/785/080 | In distribution | ||
| 6959 | In distribution | ||
| 101/893/090 | In distribution | ||
| 100/856/100 | In distribution | ||
| 6957 | In distribution | ||
| 101/815/060 | In distribution | ||
| 597080 | In distribution | ||
| 100/782/090 | In distribution | ||
| 101/860/090 | In distribution | ||
| 100/899/070 | In distribution | ||
| 101/856/070 | In distribution | ||
| 512060 | In distribution | ||
| 526100 | In distribution | ||
| 100/897/090 | In distribution | ||
| 100/826/085 | In distribution | ||
| 101/851/070 | In distribution | ||
| 500100 | In distribution | ||
| 101/816/070 | In distribution | ||
| 101/541/080 | In distribution | ||
| 100/826/080 | In distribution | ||
| 101/858/100 | In distribution | ||
| 100/782/070 | In distribution | ||
| 100/891/180 | In distribution | ||
| 101/573/000 | In distribution | ||
| 100/817/060 | In distribution | ||
| 101/810/090CZ | In distribution | ||
| 100/816/070 | In distribution | ||
| 100/781/070 | In distribution | ||
| 100/892/200CZ | 5 | In distribution | |
| 512080 | In distribution | ||
| 526080 | In distribution | ||
| 100/815/075 | In distribution | ||
| 101/816/100 | In distribution | ||
| 101/800/085CZ | In distribution | ||
| 101/810/075 | In distribution | ||
| 100/549/000CZ | In distribution | ||
| 101/856/060 | In distribution | ||
| 100/784/070 | In distribution | ||
| 100/875/100 | In distribution | ||
| 101/815/075 | In distribution | ||
| 101/800/100CZ | In distribution | ||
| 100/817/090 | In distribution | ||
| 100/597/080 | In distribution | ||
| 101/563/080 | In distribution | ||
| 101/851/100CZ | In distribution | ||
| 101/802/085 | In distribution | ||
| 101/813/060CZ | In distribution | ||
| 101/815/085 | In distribution | ||
| 101/860/100 | In distribution | ||
| 101/802/070 | In distribution | ||
| 100/875/070 | In distribution | ||
| 101/812/080CZ | In distribution | ||
| 101/875/075 | In distribution | ||
| 100/858/090 | In distribution | ||
| 101/858/080 | In distribution | ||
| 563090 | In distribution | ||
| 101/810/070 | In distribution | ||
| 101/811/100CZ | In distribution | ||
| 100/885/070 | In distribution | ||
| 100/815/090 | In distribution | ||
| 101/851/060CZ | In distribution | ||
| 101/802/060 | In distribution | ||
| 101/851/085 | In distribution | ||
| 100/870/080CZ | In distribution | ||
| 101/860/080CZ | In distribution | ||
| 101/870/080 | In distribution | ||
| 101/870/075CZ | In distribution | ||
| 101/812/070CZ | In distribution | ||
| 100/541/070CZ | In distribution | ||
| 101/860/070 | In distribution | ||
| 101/811/090CZ | In distribution | ||
| 563100 | In distribution | ||
| 100/781/080 | In distribution | ||
| 100/818/100 | In distribution | ||
| 100/815/070 | In distribution | ||
| 100/817/070 | In distribution | ||
| 100/891/070 | In distribution | ||
| 101/813/100CZ | In distribution | ||
| 101/817/070 | In distribution | ||
| 101/802/060CZ | In distribution | ||
| 101/543/080 | In distribution | ||
| 563080 | In distribution | ||
| 101/817/100 | In distribution | ||
| 526060 | In distribution | ||
| 100/891/170 | In distribution | ||
| 100/856/085 | In distribution | ||
| 100/858/085 | In distribution | ||
| 100/870/075 | In distribution | ||
| 100/892/200 | 5 | In distribution | |
| 100/890/080CZ | In distribution | ||
| 101/811/080 | In distribution | ||
| 100/818/080 | In distribution | ||
| 101/810/060 | In distribution | ||
| 101/858/085 | In distribution | ||
| 101/800/070 | In distribution | ||
| 100/875/090 | In distribution | ||
| 101/800/080 | In distribution | ||
| 504080 | In distribution | ||
| W1139 | In distribution | ||
| 6958 | In distribution | ||
| 101/811/080CZ | In distribution | ||
| 101/851/090CZ | In distribution | ||
| 100/870/080 | In distribution | ||
| 100/790/090 | In distribution | ||
| 100/856/070 | In distribution | ||
| W1140 | In distribution | ||
| 100/890/080 | In distribution | ||
| 101/800/085 | In distribution | ||
| 101/800/060 | In distribution | ||
| 100/870/070 | In distribution | ||
| 100/897/070CZ | In distribution | ||
| 101/870/080CZ | In distribution | ||
| 101/811/075 | In distribution | ||
| 100/782/100 | In distribution | ||
| 101/812/075CZ | In distribution | ||
| 100/825/060 | In distribution | ||
| 101/800/070CZ | In distribution | ||
| 101/856/100 | In distribution | ||
| 101/870/085 | In distribution | ||
| 100/897/080 | In distribution | ||
| 101/860/085 | In distribution | ||
| 100/870/075CZ | In distribution | ||
| 100/816/075 | In distribution | ||
| 101/817/090 | In distribution | ||
| 100/782/060 | In distribution | ||
| 100/541/170 | In distribution | ||
| 101/813/080CZ | In distribution | ||
| 101/816/075 | In distribution | ||
| 101/891/080 | In distribution | ||
| 101/813/080 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tracoe® comfort | Tracoe Medical Gmbh | 1,296 |
| Pilling | Teleflex Medical LLC | 248 |
| Premier | Premier Dental Products Co. | 111 |
| Tracoe mini | Tracoe Medical Gmbh | 110 |
| Sklar® | Sklar Corporation | 70 |
| Laryngotec | Andreas Fahl Medizintechnik-Vertrieb GmbH | 66 |
| Blom | Pulmodyne Inc. | 51 |
| Montgomery® Long-Term Cannula | Boston Medical Products, Inc. | 48 |
| Bivona | ICU Medical, Inc | 37 |
| Well Lead Tracheostomy Tube | Well Lead Medical Co., Ltd. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 30 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
Recalls Naming This Product
3 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 | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 3,130 all decannulation caps | 2012-05-08 |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Portex, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | Mislabeled:Tracheostomy tube was not fenestrated as specified on the label | 11 units | 2004-03-31 |
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.