AccessGUDID - DEVICE: Durata™ (05414734503174)

GUDID

Device Identifier (DI) Information

Brand Name: Durata™
Version or Model: 7122Q-58
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7122Q-58
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734503174
Issuing Agency: GS1
Commercial Distribution End Date:
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?	MR Conditional
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
NVY	Permanent defibrillator electrodes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950022	042
P950022	105
P950022	109
P950022	110
P950022	119

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
Special Storage Condition, Specify: 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).

Clinically Relevant Size

[?]

Size Type Text
Length: 58 Centimeter

Device Record Status

Public Device Record Key: d92a52e7-868e-46d0-89b8-5d45402ba4cf
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: May 05, 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
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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