DEVICE: Durata™ (05414734502139)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35853 | Endocardial defibrillation lead |
An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LWS | Implantable cardioverter defibrillator (non-CRT) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P950022 | 049 |
P950022 | 110 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 20 and 25 Degrees Celsius |
Special Storage Condition, Specify: Store at room temp. from 68-77°F (20-25°C). Excursions permitted from 59-86°F (15-30°C). During Trans/Handling excursions allowed between 23-122°F (-5-50°C) <24 hours. |
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Length: 75 Centimeter |
Device Record Status
250b84c8-9f44-4b60-b428-8de9e37924cd
September 18, 2023
5
February 02, 2017
September 18, 2023
5
February 02, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com