Identity
- Trade Name
- Resmed Sleep Apnealink Cannula FDA UDI
- Generic Name
- Respiratory apnoea monitoring system FDA UDI
- Device Name
- Nasal Cannula PG/PSG FDA UDI
- Model / Reference
- 70710316 FDA UDI
- Description
- Nasal Cannula PG/PSG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889483610565 FDA UDI
- 510(k) Number
- K151874 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Respiratory apnoea monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Respiratory apnoea monitoring system
Resmed Sleep Apnealink Cannula by Salter Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151874 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Salter Labs
Sources (1)
- FDA UDI 20309039-960b-43dd-bebb-6d2c4b5cd9f4 34 fields · synced May 30, 2026