FDA device listing
EntraFlo,Medline Ear Syringe,Medline Irrigation Bottle,Medline Irrigation Syringe,Medline Irrigation Tray,Medline Toomey…
FDA device listing 1726233575 · Medline Industries, LP
Key facts
| Proprietary names | EntraFlo,Medline Ear Syringe,Medline Irrigation Bottle,Medline Irrigation Syringe,Medline Irrigation Tray,Medline Toomey Irrigation Syringe |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | KYZ |
| Device names | KYZ - Syringe, Irrigating (Non Dental) |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6960 |
| Review panels | General Hospital |
| Registered establishments | Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, MEDLINE INDUSTRIES, LP (Northpoint Services), Nuevo Laredo Directo al Cliente |
| Establishment registrations | 1417592, 1422634, 3015173212, 3045816907 |
| FEI numbers | 1417592, 1000514656, 3015173212, 3045816907 |
| Establishment operations | Contract Sterilizer, Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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