AccessGUDID - DEVICE: Smarttemp Infant Bluetooth Thermometer (00050428557969)

GUDID

Device Identifier (DI) Information

Brand Name: Smarttemp Infant Bluetooth Thermometer
Version or Model: WT-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428557969
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14034	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 70 and 110 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd23836b-d825-4a94-b7b0-26ef219caba8
Public Version Date: December 31, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2016