Identity
- Trade Name
- Air 10 USB Module EUDAMEDAIR 10 FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- Air10 Serial Adapter, Air10 Oximeter Adapter, Air10 Oximeter Adapter EUDAMEDAIR 10 USB MODULE FDA UDI
- Model / Reference
- 37301 EUDAMEDFDA UDI
- Description
- AIR 10 USB MODULE FDA UDI
Identifiers
- Catalog Number
- 37301 FDA UDI
- Primary DI / UDI-DI
- 00619498373017 EUDAMEDFDA UDI
- Basic UDI-DI
- 619498EC1326A EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Home CPAP unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Netherlands 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Air 10 USB Module by Resmed Pty Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 619498EC1326A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ResMed PTY LTD
- EUDAMED SRN
- AU-MF-000011753
- Authorised Representative
- ResMed SAS FR-AR-000007151
Sources (2)
- EUDAMED 821fc766-176a-4513-9815-a046a8e9bad3 61 fields · synced Jul 14, 2026
- FDA UDI 6a82c415-f280-46b2-b2ae-bff02c9bc187 36 fields · synced May 30, 2026