FDA device listing
Hemanext ONE
FDA device listing 1549595973 · Hemanext Inc.
Key facts
| Proprietary names | Hemanext ONE |
|---|---|
| Owner/operator | Hemanext Inc. |
| Owner/operator number | 10049356 |
| Premarket submissions | BK251294 |
| Product codes | QYC |
| Device names | QYC - Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.9115 |
| Review panels | Hematology |
| Registered establishments | HEMANEXT INC., New Health Sciences Manufacturing |
| Establishment registrations | 3018733946, 3044771515 |
| FEI numbers | 3018733946, 3044771515 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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