FDA device listing
Aquapak Humidifier Reservoir with Adaptor,Aquapak Nebulizer Reservoir with Adaptor,Comfort Flo Humidification…
FDA device listing 1337228641 · Medline Industries, LP
Key facts
| Proprietary names | Aquapak Humidifier Reservoir with Adaptor,Aquapak Nebulizer Reservoir with Adaptor,Comfort Flo Humidification System,Gibeck Humid-Flo and Passive Kits,Hudson RCI Circuit / Column Kits,Hudson RCI Conventional Breathing Circuit with Filter,Hudson RCI Conventional Breathing Circuit with Nebulizer,ISO GARD Breathing Circuit Kit,Medline Humidifier Nebulizer Kit,Oxygen Therapy Start-Up Kit |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | OGG |
| Device names | OGG - Humidifier Nebulizer Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5450 |
| Review panels | Anesthesiology |
| Registered establishments | Medline Industries - Arlington Heights, MEDLINE INDUSTRIES, LP - Northfield, Medline Operations Germany GMBH, PRODUCTOS MEDLINE S.A. DE C.V., RCI HUDSON DE MEXICO S. DE RL. DE CV. |
| Establishment registrations | 1417411, 1417592, 3004122598, 3012543139, 3029706818 |
| FEI numbers | 1417411, 1417592, 3004122598, 3012543139, 3029706818 |
| Establishment operations | Foreign Exporter, 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