FDA device listing
Needle,Hypodermic Single Lumen
FDA device listing 1646872717 · Medline Industries, LP
Key facts
| Proprietary names | Needle,Hypodermic Single Lumen |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Premarket submissions | K112057 |
| Product codes | FMF, FMI |
| Device names | FMF - Syringe, Piston, FMI - Needle, Hypodermic, Single Lumen |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5570, 880.5860 |
| Review panels | General Hospital |
| Registered establishments | MEDLINE INDUSTRIES, LP - Northfield |
| Establishment registrations | 1417592 |
| FEI numbers | 1417592 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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