LEAD 6416-100 5BX TEMP FIX 100 CM 10L Medical Device Identification

GUDID 10885074212798

LEAD 6416-100 5BX TEMP FIX 100 CM 10L

MEDTRONIC, INC.

Endocardial pacing lead

Primary Device ID	10885074212798
NIH Device Record Key	6f17310c-8eca-4161-bb8f-cf6e21b1bfec
Commercial Distribution Status	In Commercial Distribution
Version Model Number	6416-100
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
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
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	00885074212791 [Unit of Use]
GS1	10885074212798 [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	4
Public Version Date	2021-02-05
Device Publish Date	2015-06-11

Devices Manufactured by MEDTRONIC, INC.

00199150042098 - NA	2025-09-08 CUSTOM PACK BB8B09R20 HLN OR INFANT
00199150042661 - NA	2025-09-08 CUSTOM PACK BB0C01R32 EVL 1/4 SUPPT
00199150042753 - NA	2025-09-08 CUSTOM PACK BB9F06R5 EVL WCH NEONA
00199150043392 - NA	2025-09-08 CUSTOM PACK BB12D74R5 HLO ALLIDON
00199150043507 - NA	2025-09-08 CUSTOM PACK BB12Q89R1 EVL 3/8
00199150043538 - NA	2025-09-08 CUSTOM PACK BB12Q60R1 HLO ST BERNAR
00199150044436 - NA	2025-09-08 CUSTOM PACK BB9R01R23 HLN OR PEDIA
20199150044454 - NA	2025-09-08 CUSTOM PACK BB12R78R 5PK ACC PDEVL