Cortrak 2 EAS Electromagnetic Transmitting Stylet and Corflo Feeding Tube
Feeding tube non weighted with stylet and anti-IV connector, for use with CORTRAK 2 Enteral Access System
3manufacturers in China registered for this device type
7catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Record
| Listed by | Corpak Medsystems, United States |
|---|---|
| FDA product code | FPD |
| Device type | Tube, Feeding |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Record published | 2016-08-04 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Sizes | Length 36 to 55 in; catheter gauge 8 to 12 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-9431TRAK2A | 10 FR (3.3mm) X 43″ (109cm) | In distribution |
| 20-9551TRAK2A | Catheter Gauge 10 Fr | In distribution |
| 20-9558TRAK2A | Length 55 in | In distribution |
| 20-9438TRAK2A | Length 43 in | In distribution |
| 20-9432TRAK2A | 12 FR (4mm) X 43″ (109cm) | In distribution |
| 20-9361TRAK2A | Catheter Gauge 10 Fr | In distribution |
| 20-9368TRAK2A | Catheter Gauge 8 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vygon | Vygon Corp. | 236 |
| Ameritus | Kentec Medical, LLC | 83 |
| Avanos | Avanos Medical, Inc. | 51 |
| Halyard | Avanos Medical, Inc. | 50 |
| Ameritus ENFit | Kentec Medical, LLC | 38 |
| MED-RX | Canadian Hospital Specialties Ltd. | 28 |
| DeRoyal | Deroyal Industries, Inc. | 20 |
| ENFit SIL Feeding Tube | Avanos Medical, Inc. | 18 |
| NeoConnect Enteral Feeding Tube | Neomed Co., Ltd. | 18 |
| TubeClear | Actuated Medical, Inc. | 14 |
| Corflo Ultra Lite NG | Corpak Medsystems | 13 |
| Aquarius | Degania Silicone, Ltd. | 11 |
Showing 12 of 33. All products under Tube, Feeding
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K083776 | 2009-03-05 |
| K083791 | 2009-03-04 |
| K083786 | 2009-02-20 |
| K083210 | 2008-12-29 |
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.