Flexon

Basic Information

• Brand Name: Flexon
• Primary DI: 10884521103788
• Version / Model: 88862615-53
• Catalog Number: 88862615-53
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-31
• Public Version: 4
• Public Version Date: 2018-11-23
• Public Version Status: Update
• Public Device Record Key: 42bbca41-301b-40e8-9c7c-30b2f4f6a1b5

Device Description

Multifilament Temporary Cardiac Pacing Lead

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDF	ELECTRODE, PACEMAKER, TEMPORARY	Cardiovascular	870.3680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45966	Transthoracic pacing lead	A flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor between the heart and an external temporary pacing/defibrillation device used to treat postoperative cardiac arrhythmias/cardiac arrests. The electrode end is attached to the myocardium. The other end initially is typically attached to a removable needle used to perforate the chest wall from the inside out, after which it is connected to a pulse generator, typically via an adaptor. This device is only used for temporary pacing of the heart and is removed once the patient is stable. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521103785	GS1	CASE	12	In Commercial Distribution
Primary	10884521103788	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K955722	000

Device Sizes

Type	Value	Unit	Text
Length	24	Inch
Device Size Text, specify			diameter,2/0,N/A;

Storage Conditions

• Type: Special Storage Condition, Specify