LEAD 6416-200 TEMP PAC LEAD 1PK US Medical Device Identification

GUDID 00643169372764

LEAD 6416-200 TEMP PAC LEAD 1PK US

MEDTRONIC, INC.

Endocardial pacing lead

Primary Device ID	00643169372764
NIH Device Record Key	c5c6026f-1e21-4f49-a9af-54539c07be48
Commercial Distribution Discontinuation	2018-04-23
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	6416-200
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
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
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

Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter
Length	200 Centimeter

Operating and Storage Conditions

Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169372764 [Primary]
GS1	20643169372768 [Package] Package: PK [5 Units] Discontinued: 2018-04-23 Not in Commercial Distribution

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	4
Public Version Date	2019-07-15
Device Publish Date	2015-10-27

Devices Manufactured by MEDTRONIC, INC.

00199150000012 - NA	2025-03-07 CUSTOM PACK BB10J80R7 1/4CNTRI
00763000997984 - NA	2025-03-07 CUSTOM PACK BB11F56R9 PEDS V
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