FUKUDA DENSHI

Basic Information

• Brand Name: FUKUDA DENSHI
• Primary DI: 04538612915994
• Version / Model: CIE-01B
• Company Name: FUKUDA DENSHI CO.,LTD.
• Labeler DUNS: 690671011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-16
• Public Version: 1
• Public Version Date: 2024-04-24
• Public Version Status: New
• Public Device Record Key: 6ec5b5cc-3516-4c6c-970a-5ce66be6ba5b

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37176	Patient monitoring system module, electrocardiographic, telemetric	A small unit dedicated for the receipt of wireless electrocardiogram (ECG) signals sent from an ambulatory patient so that the electrical activity of the patient's heart can be monitored when the patient is remote to the patient monitoring system. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG signal information received and provided by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04538612915994	GS1

Premarket Submissions

Submission Number	Supplement Number
K173226	000