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Series Oro-Nasal Masks
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 201622Model 6450; 7450 - Series Oro-Nasal Masks
Identity
- Trade Name
- 7450 RV2 MASK FDA UDI
- Generic Name
- Pulmonary function valve FDA UDI
- Device Name
- Series Oro-Nasal Masks EUDAMED7450 LARGE FACE MASK-HEADGEAR FDA UDI
- Model / Reference
- 6450; 7450 - Series Oro-Nasal Masks EUDAMED201622 EUDAMED7450 FDA UDI
- Description
- 7450 LARGE FACE MASK-HEADGEAR FDA UDI
Identifiers
- Catalog Number
- 201622 FDA UDI
- Primary DI / UDI-DI
- 00874750004645 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691178BZ EUDAMED
- Direct Marketing DI
- 00874750004645 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
Series Oro-Nasal Masks by Hans Rudolph, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- 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 b7862e5e-251d-439f-9c16-e5f58efdff09 61 fields · synced May 29, 2026
- FDA UDI 039eb98b-c0c6-4166-ab38-1e43a9a79751 34 fields · synced May 29, 2026