LEAD WIRE,PINCH TO NIHON KONDEN,INTERMED

Basic Information

• Brand Name: LEAD WIRE,PINCH TO NIHON KONDEN,INTERMED
• Primary DI: 90840828101045
• Version / Model: DLW-06BF-MXAN-3000
• Catalog Number: 18604
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• Labeler DUNS: 796452311
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 3535525f-6075-46d8-a743-df3c76f993e6
• Distribution End Date: 2017-12-28

Device Description

LEAD WIRE,PINCH TO NIHON KONDEN,INTERMED

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Lot/Batch Number: No
• 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
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	870.2900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	90840828101519	GS1		2	Not in Commercial Distribution	2017-12-28
Primary	90840828101045	GS1
Package	90840828101199	GS1		10	Not in Commercial Distribution	2017-12-28

Customer Contacts

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