Identity
- Trade Name
- SleepmateAC Model (snoring & flow), includes 5 Nasal + Cannulas FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- AC Model (snoring & flow) FDA UDI
- Model / Reference
- 814330-100 FDA UDI
- Description
- AC Model (snoring & flow) FDA UDI
Identifiers
- Catalog Number
- 814330-100 FDA UDI
- Primary DI / UDI-DI
- 05707480041671 FDA UDI
- 510(k) Number
- K922112 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Polysomnograph FDA UDI
- Models / Variants
- (snoring FDA UDIflow) FDA UDIincludes 5 Nasal + Cannulas FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- Not 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
SleepmateAC Model - (snoring by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS
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, Adult — 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 fcf998e9-3bcb-4084-8c96-e5a133bbedb1 37 fields · synced Jun 1, 2026