← Back to catalogue
Heated Humidifier ES
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ES6HModel System One Heated Humidifier
Identity
- Trade Name
- Heated Humidifier ES EUDAMEDSystem One FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- System One Heated Humidifier, Spain FDA UDI
- Model / Reference
- System One Heated Humidifier EUDAMEDES6H EUDAMEDSystem One Heated Humidifier, ES FDA UDI
- Description
- System One Heated Humidifier, Spain FDA UDI
Identifiers
- Catalog Number
- ES6H FDA UDI
- Primary DI / UDI-DI
- 00606959029361 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959029361 EUDAMED
- 510(k) Number
- K113068 FDA UDI
- FDA Product Code
- BZD 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
- 868.5905 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Heated Humidifier ES by Respironics, Inc. — 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-00606959029361 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 8d34c32f-b558-4852-b471-d500dc02b6a4 61 fields · synced Jun 19, 2026
- FDA UDI 5a7e1f96-a54a-4e16-9f9a-ff38f30515d5 37 fields · synced May 29, 2026
- EUDAMED 85e4ee1b-a64a-44a5-bd6b-2922700e0648 61 fields · synced Jun 19, 2026