Identity
- Trade Name
- REMOTE ALARM FDA UDI
- Generic Name
- Airway pressure alarm FDA UDI
- Device Name
- REMOTE ALARM II CABLE 20M FDA UDI
- Model / Reference
- 27907 FDA UDI
- Description
- REMOTE ALARM II CABLE 20M FDA UDI
Identifiers
- Catalog Number
- 27907 FDA UDI
- Primary DI / UDI-DI
- 00619498279074 FDA UDI
- FDA Product Code
- MNT FDA UDI
- GMDN Term
- Airway pressure alarm FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Airway pressure alarm
Remote Alarm by Resmed Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Airway pressure alarm.
- EM — Allied Medical LLC
- REMOTE ALARM — Resmed Corp · Class II
- Remote Alarm — Respironics, Inc. · Class II
- REMOTE ALARM — RESMED PTY LTD · Class II
- HOSPITAL ALARM — RESMED PTY LTD · Class II
- REMOTE ALARM — RESMED PTY LTD · Class II
- REMOTE ALARM — RESMED PTY LTD · Class II
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 a3f524fa-688a-4ceb-844d-45df272b742e 35 fields · synced May 30, 2026