AccessGUDID - DEVICE: Durata® (05414734505116)

GUDID

Device Identifier (DI) Information

Brand Name: Durata®
Version or Model: 7131-60
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7131-60
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734505116
Issuing Agency: GS1
Commercial Distribution End Date: February 13, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Defibrillation Lead

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Centimeter

Device Record Status

Public Device Record Key: b05696f3-6628-4ff9-abb7-adf5fa366518
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: January 25, 2017