FDA device listing
Medline / CDS catheter care tray (kit),Medline Foley Catheterization Tray,Medline Urethral Catheterization Tray
FDA device listing 1054677647 · Medline Industries, LP
Key facts
| Proprietary names | Medline / CDS catheter care tray (kit),Medline Foley Catheterization Tray,Medline Urethral Catheterization Tray |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | OHR |
| Device names | OHR - Catheter Care Tray |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5130 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, MEDLINE INDUSTRIES, LP - SPT, Medline Soluciones Medicas, Nuevo Laredo Directo al Cliente, PRODUCTOS MEDLINE S.A. DE C.V. |
| Establishment registrations | 1417592, 1423395, 3004122598, 3005595283, 3015173212, 3045816902, 3045816907 |
| FEI numbers | 1417592, 3000717925, 3004122598, 3005595283, 3015173212, 3045816902, 3045816907 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Sterilizer, Manufacturer, Repackager/Relabeler |
| 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