DEVICE: EQUALINE (00041163495777)

Device Identifier (DI) Information

EQUALINE
KD-181
In Commercial Distribution

SUPERVALU INC.
00041163495777
GS1

1
006961411 *Terms of Use
A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to to measure a patient's body temperature. The device has a flexible tip and an LCD display. It is designed to take a temperature reading in approximately 30 seconds. This is a reusable device.
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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.
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FDA Product Code

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Product Code Product Code Name
FLL Thermometer, Electronic, Clinical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 Record Status

873717ae-6651-40e3-8e35-868d6dc5b118
March 29, 2018
2
September 20, 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
40041163495775 24 20041163495771 In Commercial Distribution case
20041163495771 6 00041163495777 In Commercial Distribution inner 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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Yes
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Customer Contact

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No Customer Contact currently defined
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