OPTISURE™ LDA230Q-58

GUDID 05414734507387

Defibrillation Lead

ST. JUDE MEDICAL, INC.

Endocardial defibrillation lead
Primary Device ID05414734507387
NIH Device Record Key1f790e86-c396-4d21-886f-0d657477a8bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTISURE™
Version Model NumberLDA230Q-58
Catalog NumberLDA230Q-58
Company DUNS790268031
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
Special Storage Condition, SpecifyBetween 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734507387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVYPermanent defibrillator electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-27
Device Publish Date2017-04-10

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Trademark Results [OPTISURE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTISURE
OPTISURE
86888476 5210312 Live/Registered
K-Too, LLC
2016-01-27
OPTISURE
OPTISURE
86888443 5210311 Live/Registered
K-Too, LLC
2016-01-27
OPTISURE
OPTISURE
85735749 4538738 Live/Registered
Pacesetter, Inc.
2012-09-21
OPTISURE
OPTISURE
78582606 3163938 Live/Registered
ROCHE DIAGNOSTICS GMBH
2005-03-08
OPTISURE
OPTISURE
76157136 2592778 Dead/Cancelled
HEALHWAYS MY EPHIT, LLC
2000-10-31

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