Tapsystem

Basic Information

• Brand Name: Tapsystem
• Primary DI: 00856233005073
• Version / Model: 2A Patient Cable
• Catalog Number: 2010
• Company Name: CARDIOCOMMAND, INC.
• Labeler DUNS: 800214827
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1956b9de-05bb-4a4e-85be-3b73141bbe92

Device Description

A cable used to connect a patient to a Model 2A pulse generator system for the treatment of cardiac dysrhythmias.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPA	System, Esophageal Pacing	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
44862	Temporary cardiac pacing/stimulation connection cable, reusable	A flexible wire, insulated with non-conductive material except at its ends, that provides a connection between an external temporary pacemaker and implanted cardiac pacing leads, to transmit electrical impulses to the heart and possibly relay information about the heart's activity back to the pacemaker. The proximal end plugs into a temporary pacemaker or an adaptor (e.g., when the cable/lead does not meet original design), and the distal end, which may consist of a connector block to accommodate different connection configurations, connects to the pacing leads/heart wires (e.g., IS-1 leads). This is a reusable device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856233005073	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P840002	000