FDA device listing
Recharger belt,Recharger Drape,Screening belt
FDA device listing 1085522967 · Medtronic, Inc.
Key facts
| Proprietary names | Recharger belt,Recharger Drape,Screening belt |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Product codes | OAG |
| Device names | OAG - Garment, Storage, Peritoneal Dialysis Catheter |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5050 |
| Review panels | Physical Medicine |
| Registered establishments | Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC NEUROMODULATION |
| Establishment registrations | 2182207, 3018094310 |
| FEI numbers | 2182207, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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