AccessGUDID - DEVICE: EnSite™ (05415067033499)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 05415067033499
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 ECG Output Module

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?
64392	Electrical-only medical device connection adaptor, reusable	A device intended to allow electrical connection of incompatible plugs/sockets on related medical devices (e.g., generator and controller) and/or cables. This device will typically be used when the system components are from different manufacturers or using different technologies, and the original connectors are not compatible; it has no additional non-electrical conduction 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 [?]
K202066	000
K221213	000
K223094	000
K231415	000
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
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
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54fa62ae-250e-42ac-8a3f-d2124a67a435
Public Version Date: February 06, 2025
Public Version Number: 5
DI Record Publish Date: January 06, 2021