AccessGUDID - DEVICE: EP-Connect (00856233005097)

GUDID

Device Identifier (DI) Information

Brand Name: EP-Connect
Version or Model: Octapolar
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8032
Company Name: CARDIOCOMMAND, INC.

Primary DI Number: 00856233005097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800214827 *Terms of Use

Device Description: A 10 ft. cable that connects Model 1600 Octapolar catheter products to ECG recorders using modular to pin connector.

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?
47483	Electrocardiographic lead/catheter adaptor	A small, sterile, connecting device that enables a mechanical union between an in situ cardiac catheter [e.g., an electrophysiology (EP) diagnostic catheter] and an electrocardiograph (ECG) cable/lead for transmission of heart signals to an ECG machine. This device allows the connection of the otherwise incompatible connectors of the cardiac catheter to a standard ECG cable/lead or a cable/lead of different manufacture. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905831	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73695c21-fc98-4115-b67a-545748254066
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 03, 2015