Identity
- Trade Name
- RESMED FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- MEDICAL OXYGEN SENSOR FDA UDI
- Model / Reference
- 27935 FDA UDI
- Description
- MEDICAL OXYGEN SENSOR FDA UDI
Identifiers
- Catalog Number
- 27935 FDA UDI
- Primary DI / UDI-DI
- 00619498279357 FDA UDI
- 510(k) Number
- K082655 FDA UDI
- FDA Product Code
- CCL FDA UDI
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Portable electric ventilator
Resmed by Resmed Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable electric ventilator.
- VOCSN Patient Breathing Package — VENTEC LIFE SYSTEMS, INC. · Class II
- Trilogy — Respironics, Inc. · Class I
- DreamStation — Respironics, Inc. · Class II
- DreamStation — Respironics, Inc. · Class II
- BiPAP A40 — Respironics, Inc. · Class II
- DreamStation — Respironics, Inc. · Class II
- DreamStation BiPAP AVAPS — Respironics, Inc. · Class II
- DreamStation BiPAP AVAPS — Respironics, Inc. · Class II
Cleared under the same submission
K082655 also covers:
- Oxygen Sensor — Honeywell Healthcare Solutions GmbH
- Oxygen Sensor — Honeywell Healthcare Solutions GmbH
- Oxygen Sensor — Honeywell Healthcare Solutions GmbH
- Oxygen Sensor — Honeywell Healthcare Solutions GmbH
- Oxygen Sensor — Honeywell Healthcare Solutions GmbH
- Oxygen Sensor — Honeywell Healthcare Solutions GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Resmed Pty Ltd
Sources (1)
- FDA UDI 20dd46b1-b683-41f9-a70e-d5f883808c28 36 fields · synced Jun 1, 2026