Identity
- Trade Name
- AIR11 FILTER, HYPO, 50 PACK EUDAMEDAIR 11 FDA UDI
- Generic Name
- Heat/moisture exchanger insertable filter FDA UDI
- Device Name
- S9/Air 10 Hypoallergenic Filters, Air11 Hypoallergenic Filter, AirMini Hypoallergenic Filters EUDAMEDAIR11 FILTER, HYPO, 50 PACK FDA UDI
- Model / Reference
- 39307 EUDAMEDFDA UDI
- Description
- AIR11 FILTER, HYPO, 50 PACK FDA UDI
Identifiers
- Catalog Number
- 39307 FDA UDI
- Primary DI / UDI-DI
- 00619498393077 EUDAMEDFDA UDI
- Basic UDI-DI
- 619498EC13168 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
- GMDN Term
- Heat/moisture exchanger insertable filter FDA UDI
Classification
- Device Class
- Class IIa 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
Air11 Filter, Hypo, 50 Pack by Resmed Pty Ltd — Class IIa — 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 | 619498EC13168 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 8be1ce79-5216-4ca0-b57a-7e84d435caed 61 fields · synced Jul 9, 2026
- FDA UDI 43fffccc-cd05-4acd-a2db-9427513f59a0 36 fields · synced May 29, 2026