NA

Basic Information

• Brand Name: NA
• Primary DI: 20613994412984
• Version / Model: 6416-200
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2015-06-11
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 07e4dc3b-1035-44c2-ba4d-b26a33096034
• Distribution End Date: 2016-10-09

Device Description

LEAD 6416-200 5BX TEMP FIX LEAD 10L

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: No
• 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
35223	Endocardial pacing lead	An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20613994412984	GS1
Unit of Use	00613994412980	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042190	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter length 90 cm
Device Size Text, specify			Lead length 200 cm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit