Identity
- Trade Name
- SmartMonitor 2 w/ Modem FDA UDI
- Generic Name
- Infant apnoea monitor FDA UDI
- Device Name
- SmartMonitor 2 w/ Modem FDA UDI
- Model / Reference
- 4003 FDA UDI
- Description
- SmartMonitor 2 w/ Modem FDA UDI
Identifiers
- Catalog Number
- 4003 FDA UDI
- Primary DI / UDI-DI
- B0364003 FDA UDI
- 510(k) Number
- K011597 FDA UDI
- FDA Product Code
- FLS FDA UDI
- GMDN Term
- Infant apnoea monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2377 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infant apnoea monitor
SmartMonitor 2 w/ Modem by Circadiance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K011597 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 |
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Manufacturer
- Manufacturer
- Circadiance
Sources (1)
- FDA UDI e89e13e9-c75c-4055-9292-0d04e6826d9d 37 fields · synced Jun 9, 2026