Identity
- Trade Name
- ThermiSense FDA UDI
- Generic Name
- Respiratory apnoea monitoring system FDA UDI
- Device Name
- ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable. FDA UDI
- Model / Reference
- 5700PE-0-1 FDA UDI
- Description
- ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable. FDA UDI
Identifiers
- Catalog Number
- 5700PE-0-1 FDA UDI
- Primary DI / UDI-DI
- 10607411000307 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Respiratory apnoea monitoring system
ThermiSense by Salter Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory apnoea monitoring system.
- ThermiSense — SALTER LABS · Class II
- ThermiSense — SALTER LABS · Class II
- PneumoTherm — SALTER LABS · Class II
- ThermiSense — SALTER LABS · Class II
- ThermiSense — SALTER LABS · Class II
- ThermiSense — SALTER LABS · Class II
- BiNAPS — SALTER LABS · Class II
- ThermiSense — SALTER LABS · Class II
Cleared under the same submission
K151874 also covers:
- BiNAPS — SALTER LABS
- Resmed Sleep Apnealink Cannula — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
- ThermiSense — SALTER LABS
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
- Salter Labs
Sources (1)
- FDA UDI 1e56abee-cc05-4fbc-92b7-8a7af4974d99 38 fields · synced May 30, 2026