LABELING CHANGE - VIASPAN(TM) (BELZER UW)
Device Facts
| Record ID | K900492 |
|---|---|
| Device Name | LABELING CHANGE - VIASPAN(TM) (BELZER UW) |
| Applicant | The DU Pont Co. |
| Product Code | KDL · Gastroenterology, Urology |
| Decision Date | Mar 20, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.
