Durata® 7130-60
GUDID H75871306009
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 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 Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead| Primary Device ID | H75871306009 |
| NIH Device Record Key | e6535b46-c98a-4acc-871a-8107a22b703d |
| Commercial Distribution Discontinuation | 2018-02-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Durata® |
| Version Model Number | 7130-60 |
| Catalog Number | 7130-60 |
| 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 |
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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| 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 |
| 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 |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
Operating and Storage Conditions
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Yes |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734505086 [Primary] |
| HIBCC | H75871306009 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P950022
FDA Product Code
| LWS | Implantable cardioverter defibrillator (non-CRT) |
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 | 2014-09-29 |
On-Brand Devices [Durata®]
| 05414734505123 | Defibrillation Lead |
| 05414734505116 | Defibrillation Lead |
| H75871306009 | Defibrillation Lead |
Trademark Results [Durata]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURATA 98346652 not registered Live/Pending |
Cambrige Overseas Development, Inc. 2024-01-08 |
 DURATA 86198617 4623953 Live/Registered |
Ply Gem Industries, Inc. 2014-02-20 |
 DURATA 85059782 3952624 Dead/Cancelled |
Primo Design Importers Ltd. 2010-06-10 |
 DURATA 79094748 4075853 Live/Registered |
Sichuan Huajing Guomao Industrial Co., Ltd. 2011-02-22 |
 DURATA 79071857 3838059 Live/Registered |
SICHUAN HUAJING GUOMAO INDUSTRIAL CO.,LTD. 2009-06-16 |
 DURATA 79007737 3100931 Live/Registered |
SICHUAN HUAJING GUOMAO INDUSTRIAL CO., LTD. 2004-11-29 |
 DURATA 77413144 3539797 Live/Registered |
Grothouse Jr, Arthur Paul 2008-03-04 |
 DURATA 77012820 3462928 Live/Registered |
Pacesetter, Inc. 2006-10-03 |
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