EUDAMED device
FitPack, DreamWisp Nsl, Med Con w/o Hgr GBL (S, M, L Cushions)
EUDAMED device 00606959050983 · Respironics Inc.
Key facts
| Primary DI | 00606959050983 |
|---|---|
| Trade name | FitPack, DreamWisp Nsl, Med Con w/o Hgr GBL (S, M, L Cushions) |
| Reference or catalog number | 1137918 |
| Model | DreamWisp Nasal Mask with Over the Nose Cushion |
| Manufacturer | Respironics Inc. |
| Manufacturer SRN | US-MF-000002301 |
| Risk class | Class IIa |
| EMDN code | R0301010202 |
| EMDN description | NIV MASKS |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jul 22, 2025 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: