DEVICE: OCCObaby (00863101000320)

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Device Identifier (DI) Information

OCCObaby
OCCOscan OCCOflex Bundle

DEOCCO LLC
00863101000320
GS1
1
Bundle of two thermometers: OCCOscan - The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. OCCOflex - Digital Thermometer enables fast and reliable measurements. These thermometers provide very high clinical accuracy and have been designed to provide maximum user-friendliness. Digital Thermometer series can be used in conjunction with or without a disposable probe cover when preferred. The basic principle of these thermometers is that a change of thermistor resistance, caused by changes in temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, the temperature can be given by measuring the frequency of the oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Intermittent electronic patient thermometer A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.
Infrared patient thermometer, skin A hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FLL Thermometer, Electronic, Clinical
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Sterilization

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

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Storage and Handling
No storage/handling found
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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
September 23, 2016

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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
10863101000327 50 00863101000320 In Commercial Distribution carton
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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