DEVICE: Durata™ (05414734503341)

Download: XML | JSON

Device Identifier (DI) Information

Durata™
7122Q-65
7122Q-65
ST. JUDE MEDICAL, INC.
05414734503341
GS1
1
Defibrillation Lead
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endocardial defibrillation lead A sterile, 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NVY Permanent defibrillator electrodes
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Special Storage Condition, Specify: Yes
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 65 Centimeter
CLOSE

Device Status

In Commercial Distribution
April 10, 2017

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
CLOSE