Identity
- Trade Name
- ResMed Oxygen Connector Port EUDAMEDOXYGEN PORT FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Oxygen Connector Port EUDAMEDOXYGEN PORT FDA UDI
- Model / Reference
- 26960 EUDAMEDFDA UDI
- Description
- OXYGEN PORT FDA UDI
Identifiers
- Catalog Number
- 26960 FDA UDI
- Primary DI / UDI-DI
- 00619498269600 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00619498269600 EUDAMED
- 510(k) Number
- K080131 FDA UDI
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R020302 RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS 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
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CPAP/BPAP face mask, reusable
Oxygen Port by Resmed Corp — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP face mask, reusable.
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- QUATTRO FX — RESMED PTY LTD · Class II
- Full Face CPAP Mask — Large — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
Cleared under the same submission
K080131 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Resmed Corp
Sources (2)
- FDA UDI 47b87f70-7c22-484e-b4da-26ccd006ef6c 37 fields · synced Jul 9, 2026
- EUDAMED 8c7566c0-6439-4930-9b04-8a17cd373db8 61 fields · synced Jul 9, 2026