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7600 V Mask
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 201523Model 7600; 7700 Series
Identity
- Trade Name
- 7600 V MASK FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Oro-Nasal Mask EUDAMEDSWVL PORT ASY 7600 22OD PC BLU FDA UDI
- Model / Reference
- 7600; 7700 Series EUDAMED201523 EUDAMED7600 FDA UDI
- Description
- SWVL PORT ASY 7600 22OD PC BLU FDA UDI
Identifiers
- Catalog Number
- 201523 FDA UDI
- Primary DI / UDI-DI
- 00874750002986 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691236BN EUDAMED
- 510(k) Number
- K030822 FDA UDI
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable 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
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: CPAP/BPAP face mask, reusable
7600 V Mask by Hans Rudolph, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K030822 also covers:
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hans Rudolph, Inc.
Sources (2)
- FDA UDI b825b5b9-f399-4b46-9f2d-3f23305e6e41 35 fields · synced Jun 19, 2026
- EUDAMED e6bd4b0f-d8b4-40f9-8040-9c657c22c922 61 fields · synced Jun 19, 2026