LEAD 6416-140 5BX TEMP FIX LEAD 10L Medical Device Identification

GUDID 10885074212804

LEAD 6416-140 5BX TEMP FIX LEAD 10L

MEDTRONIC, INC.

Endocardial pacing lead

Primary Device ID	10885074212804
NIH Device Record Key	a77a92d1-90fc-4ff0-87ad-20f9320a47de
Commercial Distribution Discontinuation	2018-04-23
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	6416-140
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	5
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074212807 [Unit of Use]
GS1	10885074212804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042190

FDA Product Code

LDF	ELECTRODE, PACEMAKER, TEMPORARY

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-02-05
Device Publish Date	2015-06-11

Devices Manufactured by MEDTRONIC, INC.

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00763000999346 - NA	2025-03-07 CUSTOM PACK BB3R67R6 SU AVLOOP
20763000999364 - NA	2025-03-07 CUSTOM PACK BB8A42R1 2PK TAVR PACK
20763000999388 - NA	2025-03-07 CUSTOM PACK BB3J83R2 5PK 38X332X16
20763000999401 - NA	2025-03-07 CUSTOM PACK BB11J01R1 5PK BRIDGE SUP
00763000999513 - NA	2025-03-07 CUSTOM PACK BB11F41R3 ADLT SUPP PAC
20763000999777 - NA	2025-03-07 CUSTOM PACK BB12M84R1 10PK 3/8 SUPP LINE