FUKUDA DENSHI

Basic Information

• Brand Name: FUKUDA DENSHI
• Primary DI: 04538612914423
• Version / Model: CUFJ-M01
• Company Name: FUKUDA DENSHI CO.,LTD.
• Labeler DUNS: 690671011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-16
• Public Version: 1
• Public Version Date: 2022-09-26
• Public Version Status: New
• Public Device Record Key: 1f46deff-b05c-4786-9774-599bcbd38803

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: 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
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64474	Luer/Luer linear connector, reusable	A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape and may include a very short length of tube between each Luer connection; it does not incorporate a filter, valve, clamp, nor puncturing component. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04538612914423	GS1

Premarket Submissions

Submission Number	Supplement Number
K980728	000