FDK

Basic Information

• Brand Name: FDK
• Primary DI: 00859020006475
• Version / Model: FT-F34
• Company Name: Fudakang Industrial Inc.
• Labeler DUNS: 118811334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-11
• Public Version: 6
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 794bfe42-761b-40c5-9179-99497b9481e6

Device Description

FDK NON-CONTACT INFRARED THERMOMETER

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: Yes
• 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
Package	10859020006472	GS1	Case	24	In Commercial Distribution
Primary	00859020006475	GS1
Package	00859020006482	GS1	Inner Pack	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K111703	000