DEVICE: Smarttemp Infant Bluetooth Thermometer (00050428557969)

Device Identifier (DI) Information

Smarttemp Infant Bluetooth Thermometer
WT-1
In Commercial Distribution

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
00050428557969
GS1
December 31, 2018
1
062312574 *Terms of Use
The smarttemp’s continuous monitoring is the easiest way to track baby’s temperature all day/night long! It sends an alert to a smart phone when fever strikes, without disturbing baby and letting baby sleep—it also provides medication reminders and allows for record keeping of medicine dosages. It’s comfortable, reliable, and safe. Using Bluetooth technology, a parent can keep baby close, but not disturb them when checking their temperature.
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Device Characteristics

MR Unsafe
No
No
No
No
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Continuous electronic patient thermometer, battery-powered A battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.
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FDA Product Code

[?]
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
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 70 and 110 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

cd23836b-d825-4a94-b7b0-26ef219caba8
March 29, 2018
2
September 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
8554222983
giuseppe@infanttech.com
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