EP-Connect 8032

GUDID 00856233005097

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

CARDIOCOMMAND, INC.

Electrocardiographic lead/catheter adaptor

• Primary Device ID: 00856233005097
• NIH Device Record Key: 73695c21-fc98-4115-b67a-545748254066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EP-Connect
• Version Model Number: Octapolar
• Catalog Number: 8032
• Company DUNS: 800214827
• Company Name: CARDIOCOMMAND, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 231-6370
• Email: cconley@CardioCommand.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856233005097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905831

FDA Product Code

• DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-04-03

Devices Manufactured by CARDIOCOMMAND, INC.

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• 00856233005110 - Model 7A: 2018-10-05 Interface cable between 7A Stimulator and Model 3 preamplifier.
• 00856233005158 - Tapsystem: 2018-10-05 A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged).
• 00856233005165 - Model 7A: 2018-10-05 Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preampl
• 00856233005172 - Model 7A: 2018-10-05 Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preampl
• 00856233005004 - Tapscope: 2018-07-06 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a male temperature connector, (single unit pa
• 00856233005011 - Tapscope: 2018-07-06 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a female temperature connector, (single unit
• 00856233005028 - Tapscope: 2018-07-06 10 French esophageal bipolar pacing and recording catheter, (single unit package).