DEVICE: SmartMonitor 2PSL w/o Modem (B0361028971)

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Device Identifier (DI) Information

SmartMonitor 2PSL w/o Modem
1028971
1028971
CIRCADIANCE, LLC
B0361028971
HIBCC
1
SmartMonitor 2PSL w/o Modem
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
DQA Oximeter
NPF Monitor, Apnea, Home Use
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 07, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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No
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Customer Contact

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1-888-825-9640
info@circadiance.com
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