FDA device listing
Pharma Neo,Pharma Neo Port,Pharma Trach Basic,Pharma Trach Item,Pharma Trach Multi-Function
FDA device listing 1013093297 · Pharma Systems AB
Key facts
| Proprietary names | Pharma Neo,Pharma Neo Port,Pharma Trach Basic,Pharma Trach Item,Pharma Trach Multi-Function |
|---|---|
| Owner/operator | Pharma Systems AB |
| Owner/operator number | 10036898 |
| Premarket submissions | K903058 |
| Product codes | BYD |
| Device names | BYD - Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5375 |
| Review panels | Anesthesiology |
| Registered establishments | PHARMA SYSTEMS AB |
| Establishment registrations | 3005519819 |
| FEI numbers | 3005519819 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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