TempTraq®

Basic Information

• Brand Name: TempTraq®
• Primary DI: 00851203006470
• Version / Model: TT-100
• Catalog Number: 647
• Company Name: BLUE SPARK TECHNOLOGIES, INC.
• Labeler DUNS: 603031365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-26
• Public Version: 2
• Public Version Date: 2026-03-13
• Public Version Status: Update
• Public Device Record Key: fe3d839c-bbf1-48d8-ac16-e63b4ded9965

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Continuous Measurement Thermometer	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62170	Wireless patient thermometer, single-use	A battery-powered electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for data display, recording and analysis. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit), and is typically used to monitor a fever during daily activities and sleep. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851203006470	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201977	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Duration: 24 Hours