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SmartMonitor 2PSL w/ Modem

FDA UDI

Class II (US FDA UDI)

by Circadiance

Identity

Trade Name
SmartMonitor 2PSL w/ Modem FDA UDI
Generic Name
Infant apnoea monitor FDA UDI
Device Name
SmartMonitor 2PSL w/ Modem FDA UDI
Model / Reference
1028970 FDA UDI
Description
SmartMonitor 2PSL w/ Modem FDA UDI

Identifiers

Catalog Number
1028970 FDA UDI
Primary DI / UDI-DI
B0361028970 FDA UDI
510(k) Number
K061256 FDA UDI
FDA Product Code
NPF FDA UDI
DQA FDA UDI
GMDN Term
Infant apnoea monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2377 FDA UDI
870.2700 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 2PSL w/ Modem by Circadiance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infant apnoea monitor.

Cleared under the same submission

K061256 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Circadiance

Sources (1)

  • FDA UDI 06221142-49fc-49ef-82f3-d62333cd1527 37 fields · synced Jun 9, 2026