FDA device listing
Medline Hyperinflation System
FDA device listing 1668467939 · Medline Industries, LP
Key facts
| Proprietary names | Medline Hyperinflation System |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Premarket submissions | K925591 |
| Product codes | BZR |
| Device names | BZR - Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5330 |
| Review panels | Anesthesiology |
| Registered establishments | Medline Soluciones Medicas, Nuevo Laredo Directo al Cliente, PRODUCTOS MEDLINE S.A. DE C.V. |
| Establishment registrations | 3004122598, 3045816902, 3045816907 |
| FEI numbers | 3004122598, 3045816902, 3045816907 |
| Establishment operations | Contract Sterilizer, Manufacturer |
| 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