FDA device listing
Pump, Infusion, Enteral
FDA device listing 1457588286 · Cardinal Health 200, LLC
Key facts
| Owner/operator | Cardinal Health 200, LLC |
|---|---|
| Owner/operator number | 9028292 |
| Premarket submissions | K040196 |
| Product codes | LZH |
| Device names | LZH - Pump, Infusion, Enteral |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5725 |
| Review panels | General Hospital |
| Registered establishments | Cardinal Health, CARDINAL HEALTH, Cardinal Health 200, LLC, Cardinal Health C/O Avarto Benelux BV, Cardinal Health Costa Rica, S.A., Cardinal Health Ireland Manufacturing Limited, Cardinal Health (Kenmex Medical Specialties), Cardinal Health K.K., CARDINAL HEALTH SINGAPORE 225 PTE LTD, Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd |
| Establishment registrations | 1423537, 1921846, 9611018, 9612030, 3005674464, 3009211636, 3011200334, 3012341425, 3014656668, 3016705853 |
| FEI numbers | 1921846, 3001236905, 3002806934, 3002808143, 3005674464, 3009211636, 3011200334, 3012341425, 3014656668, 3016705853 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 10–99 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