FDA device listing
Advance Plus Kit,Apogee,Catheter Insertion Kit,VaPro Pocket Plus Kit
FDA device listing 1886513583 · Hollister Inc.
Key facts
| Proprietary names | Advance Plus Kit,Apogee,Catheter Insertion Kit,VaPro Pocket Plus Kit |
|---|---|
| Owner/operator | Hollister Inc. |
| Owner/operator number | 1480288 |
| 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 | HOLLISTER, INC., HOLLISTER INCORPORATED, Hollister Medical India Private Limited |
| Establishment registrations | 1480288, 2320961, 3008191244 |
| FEI numbers | 1480288, 3003172243, 3008191244 |
| Establishment operations | 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