TempTraq®

Basic Information

• Brand Name: TempTraq®
• Primary DI: 00851203006142
• Version / Model: TempTraq Clinician iOS App
• Company Name: BLUE SPARK TECHNOLOGIES, INC.
• Labeler DUNS: 603031365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-07
• Public Version: 6
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 49a44de0-ec80-4c01-9d71-ac852e43d721

Device Description

TempTraq Clinician iOS App

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62169	Wireless patient monitor/sensor reporting software, layperson-use	A software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically for continuous monitoring and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed on an off-the-shelf, portable, computerized device (e.g., smartphone, tablet); it is not dedicated to bedside monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851203006142	GS1

Customer Contacts

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