FDA device listing
MAHURKAR Acute High Pressure Triple Lumen Catheter, Kits, and Trays
FDA device listing 1438690395 · Mozarc Medical US LLC
Key facts
| Proprietary names | MAHURKAR Acute High Pressure Triple Lumen Catheter, Kits, and Trays |
|---|---|
| Owner/operator | Mozarc Medical US LLC |
| Owner/operator number | 10090982 |
| Premarket submissions | K102605 |
| Product codes | NIE |
| Device names | NIE - Catheter, Hemodialysis, Triple Lumen, Non-Implanted |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5540 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | MOZARC MEDICAL US LLC |
| Establishment registrations | 3030574705 |
| FEI numbers | 3030574705 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database