Primary Device ID | 05414734507226 |
NIH Device Record Key | 8b87a3c0-a052-43d4-8c5c-9aac4ef7a536 |
Commercial Distribution Discontinuation | 2018-02-13 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | OPTISURE™¿ |
Version Model Number | LDA230-60 |
Catalog Number | LDA230-60 |
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 |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Length | 60 Centimeter |
Length | 60 Centimeter |
Length | 60 Centimeter |
Length | 60 Centimeter |
Length | 60 Centimeter |
Length | 60 Centimeter |
Length | 60 Centimeter |
Length | 60 Centimeter |
Length | 60 Centimeter |
Length | 60 Centimeter |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05414734507226 [Primary] |
NVY | Permanent defibrillator electrodes |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-04-10 |
05415067049414 - Entrant™ | 2024-05-03 VR Implantable Cardioverter Defibrillator |
05415067049421 - Gallant™ | 2024-05-03 VR Implantable Cardioverter Defibrillator |
05415067049469 - Entrant™ | 2024-05-03 DR Implantable Cardioverter Defibrillator |
05415067049476 - Gallant™ | 2024-05-03 DR Implantable Cardioverter Defibrillator |
05415067049513 - Entrant™ | 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator |
05415067049520 - Gallant™ | 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator |
05415067047700 - TriClip™ | 2024-04-22 G4 Delivery System |
05415067047724 - TriClip™ | 2024-04-22 G4 Delivery System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() OPTISURE 86888476 5210312 Live/Registered |
K-Too, LLC 2016-01-27 |
![]() OPTISURE 86888443 5210311 Live/Registered |
K-Too, LLC 2016-01-27 |
![]() OPTISURE 85735749 4538738 Live/Registered |
Pacesetter, Inc. 2012-09-21 |
![]() OPTISURE 78582606 3163938 Live/Registered |
ROCHE DIAGNOSTICS GMBH 2005-03-08 |
![]() OPTISURE 76157136 2592778 Dead/Cancelled |
HEALHWAYS MY EPHIT, LLC 2000-10-31 |