Identity
- Trade Name
- GoodKnight H2O EUDAMEDGoodKnight FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- GoodKnight H2O (GKH2O) EUDAMEDGoodKnight H2O is a heated humidifier designed to be used with PAP devices of the GoodKnight series. FDA UDI
- Model / Reference
- M-114600 EUDAMEDGoodKnight H2O FDA UDI
- Description
- GoodKnight H2O is a heated humidifier designed to be used with PAP devices of the GoodKnight series. FDA UDI
Identifiers
- Catalog Number
- M-114600 FDA UDI
- Primary DI / UDI-DI
- 03700659400301 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700659400301 EUDAMED
- FDA Product Code
- BTT FDA UDI
- EMDN Code
- R060201 ACTIVE VENTILATION HUMIDIFICATION SYSTEMS, EUDAMED
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
GoodKnight H2O by Sefam — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03700659400301 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sefam
- EUDAMED SRN
- FR-MF-000009061
Sources (2)
- EUDAMED 493fab85-c437-4e75-9626-d21f391ee8c1 61 fields · synced Jul 19, 2026
- FDA UDI a531cfff-8348-40d0-9604-ac5dfdd5d163 34 fields · synced May 30, 2026