QIR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pediatric Hemodialysis System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5861
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- FDA definition
- For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| CARPEDIEM System (DEN180055) | Bellco Srl (Now Part of Medtronic, Inc) | 2020-04-29 |
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