DEVICE: SmartMonitor 2PSL Hospital Alarm w/ Modem (B0361038140)
Device Identifier (DI) Information
SmartMonitor 2PSL Hospital Alarm w/ Modem
1038140
In Commercial Distribution
1038140
CIRCADIANCE, LLC
1038140
In Commercial Distribution
1038140
CIRCADIANCE, LLC
SmartMonitor 2PSL Hospital Alarm w/ Modem
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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36319 | Infant apnoea monitor |
A mains electricity (AC-powered) device that is used to register the respiratory rate of an infant and which gives an alarm signal (e.g., audible/visual) when the pre-set limits are exceeded caused by an extended interruption or cessation (apnoea) of the infants breathing pattern; a condition known as sudden infant death syndrome (SIDS). This will alert the infant's parent(s), child-minder or hospital staff when such life-threatening episodes occur. This device is usually connected to some form of movement sensing device, e.g., small pads placed directly under the infant or belts with sensors around the chest. It can be designed for use in the hospital/institution, or for home-use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQA | Oximeter |
NPF | Monitor, Apnea, Home Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K061256 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Battery Charge Temperature: 10ºC to 35ºC |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 65 Degrees Celsius |
Handling Environment Humidity: between 20 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 5 and 45 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
acce8933-ecf7-41e1-82b5-6f234caa82ba
July 06, 2018
3
December 07, 2015
July 06, 2018
3
December 07, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-888-825-9640
info@circadiance.com
info@circadiance.com