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Series Oro-Nasal Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 113558Model 6500; 6600; 6700 - Series Oro-Nasal MaskModel 6500; 6600; 6700 Series
Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- Series Oro-Nasal Mask EUDAMEDOro-Nasal Mask EUDAMED66 V2 ASSY EXSMALL 22OD W/HG FDA UDI
- Model / Reference
- 6500; 6600; 6700 - Series Oro-Nasal Mask EUDAMED113558 EUDAMED6500; 6600; 6700 Series EUDAMED6600 FDA UDI
- Description
- 66 V2 ASSY EXSMALL 22OD W/HG FDA UDI
Identifiers
- Catalog Number
- 113558 FDA UDI
- Primary DI / UDI-DI
- 00874750003532 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691293C2 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMEDR0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rebreathing oxygen face mask
Series Oro-Nasal Mask by Hans Rudolph, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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 | 081713602691293C2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hans Rudolph Inc
- EUDAMED SRN
- US-MF-000004498
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (3)
- EUDAMED 440a64a9-634b-46f7-b433-eaf4221f0208 61 fields · synced Jun 18, 2026
- FDA UDI f761e869-3ff2-4fb8-b4d2-883ded49b049 34 fields · synced May 30, 2026
- EUDAMED 8fad17d1-8455-4cd2-b46d-42ef25ddd6d3 61 fields · synced Jun 18, 2026