LEAD 6416-140 TEMP PAC LEAD 1PK US Medical Device Identification

GUDID 00643169372757

LEAD 6416-140 TEMP PAC LEAD 1PK US

MEDTRONIC, INC.

Endocardial pacing lead

Primary Device ID	00643169372757
NIH Device Record Key	028f8c11-cd5e-4365-9590-20c462a85261
Commercial Distribution Status	In Commercial Distribution
Version Model Number	6416-140
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	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 Centimeter
Length	140 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	00643169372757 [Primary]
GS1	20643169372751 [Package] Package: PK [5 Units] 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	3
Public Version Date	2019-07-15
Device Publish Date	2015-10-27

Devices Manufactured by MEDTRONIC, INC.

00763000989903 - NA	2024-12-30 CUSTOM PACK BB12H87R2 3/8 E PACK
00763000989729 - NA	2024-12-27 CUSTOM PACK BB8S01R5 CITRS AVL
20763000989754 - NA	2024-12-27 CUSTOM PACK BB12G31R2 4PK ENOE CPL
20763000989846 - NA	2024-12-27 CUSTOM PACK BB11L70R1 4PK CP 2013
00763000708917 - DiamondTemp™ FASTR RF Generator	2024-12-23 GENERATOR CEDTG200 FASTR RF US
00763000709051 - DiamondTemp™ Irrigation Pump	2024-12-23 IRRIGATION PUMP CEDTP100 US
00763000989156 - NA	2024-12-23 CUSTOM PACK BB11C49R9 1/4 PACK
00763000989163 - NA	2024-12-23 CUSTOM PACK BB12M25R1 TAPER BOOT