AccessGUDID - DEVICE: Capsure® EPI (00613994492340)

GUDID

Device Identifier (DI) Information

Brand Name: Capsure® EPI
Version or Model: 4968-60
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994492340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: LEAD 4968-60 US BIPOLAR EPICARDIAL 60CM

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?
35039	Epicardial pacing lead	An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pacemaker to the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is normally implanted in the outer surface of the heart (epicardium) in close contact to the wall of one of the chambers of the heart (endocardium), and the other end is connected to the pacemaker. It may be 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
NVN	Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
DTB	permanent pacemaker Electrode
NVY	Permanent defibrillator electrodes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950024	017
P950024	092

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
Storage Environment Temperature: less than 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 60.0 Centimeter

Device Record Status

Public Device Record Key: 2a4369d2-c968-4610-bf84-9890e17a5b5c
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2014