Cell Therapy 360 Wearable Tech V1

Basic Information

• Brand Name: Cell Therapy 360 Wearable Tech V1
• Primary DI: 00851203006227
• Version / Model: TT-300
• Catalog Number: 622
• Company Name: BLUE SPARK TECHNOLOGIES, INC.
• Labeler DUNS: 603031365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-10-21
• Public Version: 2
• Public Version Date: 2021-02-25
• Public Version Status: Update
• Public Device Record Key: 0cb357b4-ef90-456f-b3fc-61f2b0c9da54

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	Thermometer, Electronic, Clinical	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
Unit of Use	00851203006104	GS1
Primary	00851203006227	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Duration: 72 Hours