OPTISURE™ LDA210-65
GUDID 05414734507172
Defibrillation Lead
ST. JUDE MEDICAL, INC.
Endocardial defibrillation lead| Primary Device ID | 05414734507172 |
| NIH Device Record Key | e098b848-23ba-4255-9054-8715a0ccd0ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTISURE™ |
| Version Model Number | LDA210-65 |
| Catalog Number | LDA210-65 |
| 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 |
| 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 | |
| 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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
| Length | 65 Centimeter |
| Catheter Gauge | 8 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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, Specify | Between 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). |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734507172 [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 | 4 |
| Public Version Date | 2020-03-26 |
| Device Publish Date | 2017-04-10 |
On-Brand Devices [OPTISURE™]
| 05414734507486 | Defibrillation Lead |
| 05414734507479 | Defibrillation Lead |
| 05414734507462 | Defibrillation Lead |
| 05414734507455 | Defibrillation Lead |
| 05414734507448 | Defibrillation Lead |
| 05414734507431 | Defibrillation Lead |
| 05414734507394 | Defibrillation Lead |
| 05414734507387 | Defibrillation Lead |
| 05414734507363 | Defibrillation Lead |
| 05414734507356 | Defibrillation Lead |
| 05414734507349 | Defibrillation Lead |
| 05414734507332 | Defibrillation Lead |
| 05414734507325 | Defibrillation Lead |
| 05414734507318 | Defibrillation Lead |
| 05414734507301 | Defibrillation Lead |
| 05414734507295 | Defibrillation Lead |
| 05414734507288 | Defibrillation Lead |
| 05414734507271 | Defibrillation Lead |
| 05414734507264 | Defibrillation Lead |
| 05414734507257 | Defibrillation Lead |
| 05414734507202 | Defibrillation Lead |
| 05414734507189 | Defibrillation Lead |
| 05414734507172 | Defibrillation Lead |
| 05414734507165 | Defibrillation Lead |
Trademark Results [OPTISURE]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.