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Oro-Nasal Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 113813 Model 6450; 7450 Series
Identity
- Trade Name
- 7450 RV2 MASK FDA UDI
- Generic Name
- Pulmonary function valve FDA UDI
- Device Name
- Oro-Nasal Mask EUDAMED7450 V2 MED MASK W/HG/FLEX MA FDA UDI
- Model / Reference
- 6450; 7450 Series EUDAMED113813 EUDAMED7450 FDA UDI
- Description
- 7450 V2 MED MASK W/HG/FLEX MA FDA UDI
Identifiers
- Catalog Number
- 113813 FDA UDI
- Primary DI / UDI-DI
- 00874750005468 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691178BZ EUDAMED
- Direct Marketing DI
- 00874750005468 EUDAMED
- FDA Product Code
- KGB FDA UDI
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
- GMDN Term
- Pulmonary function valve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5570 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia face mask, single-use
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 Anaesthesia face mask, single-use.
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- Ventlab — Ventlab Corp. · Class I
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- King Mask — Ambu A/S · Class I
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 | 081713602691178BZ | 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 (2)
- EUDAMED d4be0534-aa75-4bc5-8953-4afc9b8f4320 61 fields · synced Jul 26, 2026
- FDA UDI 770200bc-66ab-4d4f-aa59-3a408acf0370 34 fields · synced May 24, 2026