CARETALK

Basic Information

• Brand Name: CARETALK
• Primary DI: 06926408700455
• Version / Model: TH1009N
• Company Name: Shenzhen Dongdixin Technology Co.,Ltd.
• Labeler DUNS: 545301488
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-07
• Public Version: 2
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: ccf43650-8d75-4036-8d54-de54be9bcdea

Device Description

The device is Non-Contact thermometer, which is intended to measure human body temperature

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
17888	Infrared patient thermometer, skin	A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06926408700455	GS1
Package	16926408700452	GS1	Box	36	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K161735	000