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7450 Rv2 Mask
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 201492AModel 6450; 7450 Series
Identity
- Trade Name
- 7450 RV2 MASK FDA UDI
- Generic Name
- Pulmonary function valve FDA UDI
- Device Name
- Oro-Nasal Mask EUDAMEDHEADGEAR SMALL REUSE 7450 PFT FDA UDI
- Model / Reference
- 6450; 7450 Series EUDAMED201492A EUDAMED7450 FDA UDI
- Description
- HEADGEAR SMALL REUSE 7450 PFT FDA UDI
Identifiers
- Catalog Number
- 201492A FDA UDI
- Primary DI / UDI-DI
- 00874750005307 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691178BZ 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: Pulmonary function valve
7450 Rv2 Mask by Hans Rudolph, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function valve.
- 7450 RV2 MASK — HANS RUDOLPH, INC. · Class I
- 7450 RV2 MASK — HANS RUDOLPH, INC. · Class I
- 7450 RV2 MASK — HANS RUDOLPH, INC. · Class I
- 7910 MASK — HANS RUDOLPH, INC. · Class I
- 7450 RV2 MASK — HANS RUDOLPH, INC. · Class I
- 7450 RV2 MASK — HANS RUDOLPH, INC. · Class I
- 7450 RV2 MASK — HANS RUDOLPH, INC. · Class I
- 6450 RV2 MASK — HANS RUDOLPH, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hans Rudolph, Inc.
Sources (2)
- FDA UDI 9fd36ee9-cd72-48a9-aca6-b92984c91b7f 34 fields · synced Jun 11, 2026
- EUDAMED 0b35c4a6-c712-4f89-b0a9-ae0998f77049 61 fields · synced Jun 11, 2026