Identity
- Trade Name
- Airflow Sensor FDA UDI
- Generic Name
- Airway temperature monitoring system FDA UDI
- Device Name
- Airflow Sensor Thermistor, Neonatal 249 FDA UDI
- Model / Reference
- Airflow Sensor Thermistor, Neonatal 249 FDA UDI
- Description
- Airflow Sensor Thermistor, Neonatal 249 FDA UDI
Identifiers
- Catalog Number
- 1078756 FDA UDI
- Primary DI / UDI-DI
- 00606959010307 FDA UDI
- 510(k) Number
- K960851 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Airway temperature 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
Yes
FDA UDI
Category: Airway temperature monitoring system
Airflow Sensor by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Airway temperature monitoring system.
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- Pro-Tech — Respironics, Inc. · Class II
Cleared under the same submission
K960851 also covers:
- Airflow Sensor — Respironics, Inc.
- Pro-Tech — Respironics, Inc.
- Pro-Tech — Respironics, Inc.
- Pro-Tech — Respironics, Inc.
- Sensor — Respironics, Inc.
- Sensor — Respironics, Inc.
- Sensor — Respironics, Inc.
- Sensor — Respironics, Inc.
- Sensor — Respironics, Inc.
- Sensor — Respironics, Inc.
- Sensor — Respironics, Inc.
- Sensor — Respironics, Inc.
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
- Respironics, Inc.
Sources (1)
- FDA UDI d0f0c68e-ac86-4e72-a2be-0194fc9e12bb 37 fields · synced Jun 8, 2026