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SleepmateDisposable AirFlow Sensor, Adult
FDA UDIClass II (US FDA UDI)
by Ambu A/S
Identity
- Trade Name
- SleepmateDisposable AirFlow Sensor, Adult FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Ref. 1426 FDA UDI
- Model / Reference
- 814303-000/20 FDA UDI
- Description
- Ref. 1426 FDA UDI
Identifiers
- Catalog Number
- 814303-000/20 FDA UDI
- Primary DI / UDI-DI
- 05707480042340 FDA UDI
- 510(k) Number
- K922112 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Polysomnograph 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polysomnograph
SleepmateDisposable AirFlow Sensor, Adult by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polysomnograph.
- Snore Sensor — Respironics, Inc. · Class II
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- Cadwell — Cadwell Industries, Inc. · Class II
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- Perfect Fit — Dymedix Diagnostics, Inc. · Class II
- micromed — Micromed, Inc. · Class II
- Cadwell — Cadwell Industries, Inc. · Class II
- Natus — Embla Systems · Class II
Cleared under the same submission
K922112 also covers:
- Sleepmate / SparepartLuer to O2 connector — Ambu A/S
- Sleepmate, CannuTherm Nasl Cannula with Filter — Ambu A/S
- SleepmateAASM CannuTherm Flow Kit (AC AirFlow Pressure, Reusable Therm — Ambu A/S
- SleepmateCannuTherm - Reusable Thermal Sensor — Ambu A/S
- SleepmateCannuTherm Kit (CannuTherm & 5 Nasal Cannulas) — Ambu A/S
- SleepmateCannuTherm Thermistor — Ambu A/S
- SleepmateCannuTherm Thermistor - Alice 3 — Ambu A/S
- SleepmateCannuTherm Thermistor Kit — Ambu A/S
- SleepmateCannuTherm Thermistor Kit - Embla — Ambu A/S
- SleepmateCannuTherm Thermocouple - 90 cm — Ambu A/S
- SleepmateCannula, Industry Standard CO2 — Ambu A/S
- SleepmateDisposable AirFlow Sensor, Small / Infant — Ambu A/S
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
- Ambu A/S
Sources (1)
- FDA UDI 69e618b9-ff1e-4e46-8036-b90a4d3841db 37 fields · synced May 30, 2026