FitLife Mask with SE, with Headgear, XLarge, INTL
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- FitLife Mask with SE, with Headgear, XLarge, INTL EUDAMEDFitLife FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- FitLife Family EUDAMEDFitLife Mask with Standard Elbow, with Headgear, Extra Large, International FDA UDI
- Model / Reference
- 1089995 EUDAMEDFitLife Mask with SE, with Headgear, XLarge, INTL FDA UDI
- Description
- FitLife Mask with Standard Elbow, with Headgear, Extra Large, International FDA UDI
Identifiers
- Catalog Number
- 1089995 FDA UDI
- Primary DI / UDI-DI
- 00606959023079 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959023079 EUDAMED
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Rebreathing oxygen face mask
FitLife Mask with SE, with Headgear, XLarge, INTL by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959023079 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED a79f51f7-fc18-4952-81bc-7edbcc7428df 61 fields · synced Jun 17, 2026
- FDA UDI b8add683-1c63-4300-831e-d01d1f3c2dfe 36 fields · synced May 29, 2026