AccessGUDID - DEVICE: EnSite™ (05415067051769)

GUDID

Device Identifier (DI) Information

Brand Name: EnSite™
Version or Model: ENSITE-PFAGEN-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ENSITE-PFAGEN-01
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067051769
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: X EP System PFA Generator Connect Cable

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, diagnostic, programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242016	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Temperature: between -25 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 406.0000 Centimeter

Device Record Status

Public Device Record Key: 2af3d07a-7d7a-4adc-a8f3-5364f72a2403
Public Version Date: August 25, 2025
Public Version Number: 1
DI Record Publish Date: August 15, 2025