FDA device listing
Disposable Syringes LL Without Needle 10ml, 100 Syringe/Bx,Disposable Syringes LL Without Needle 1ml low dead space…
FDA device listing 1901206225 · American Brands LLC
Key facts
| Proprietary names | Disposable Syringes LL Without Needle 10ml, 100 Syringe/Bx,Disposable Syringes LL Without Needle 1ml low dead space , 100 Syringe/Bx,Disposable Syringes LL Without Needle 20ml, 100 Syringe/Bx,Disposable Syringes LL Without Needle 3ml low dead space, 100 Syringe/Bx,Disposable Syringes LL Without Needle 5ml low dead space, 100 Syringe/Bx |
|---|---|
| Owner/operator | American Brands LLC |
| Owner/operator number | 10079224 |
| Premarket submissions | K191642 |
| Product codes | FMF |
| Device names | FMF - Syringe, Piston |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5860 |
| Review panels | General Hospital |
| Registered establishments | AMERICAN BRANDS LLC |
| Establishment registrations | 3017654330 |
| FEI numbers | 3017654330 |
| Establishment operations | Complaint File Establishment |
| 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