4 catalogue numbers from 157.152, listed by VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG, under Tube, Feeding. 3 manufacturers in China are registered for 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.
Record
Regulatory record for Vygon | Listed by | VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG |
| FDA product code | FPD |
| Device type | Tube, Feeding |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Record published | 2025-03-15 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Blister pack of 5, blister pack of 9 |
| UDI direct marking | Exempt |
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.