OPTISURE¿™ LDA220-75

GUDID 05414734507219

Defibrillation Lead

ST. JUDE MEDICAL, INC.

Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead

Primary Device ID	05414734507219
NIH Device Record Key	45136e6f-fba5-4a98-8e17-44329deff69b
Commercial Distribution Discontinuation	2018-02-13
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	OPTISURE¿™
Version Model Number	LDA220-75
Catalog Number	LDA220-75
Company DUNS	790268031
Company Name	ST. JUDE MEDICAL, 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	true
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	true
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(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com

Device Dimensions

Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734507219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P950022

FDA Product Code

NVY	Permanent defibrillator electrodes

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	2018-07-06
Device Publish Date	2017-04-10

On-Brand Devices [OPTISURE¿™]

05414734507370	Defibrillation Lead
05414734507240	Defibrillation Lead
05414734507233	Defibrillation Lead
05414734507219	Defibrillation Lead
05414734507196	Defibrillation Lead