Model 7A

Basic Information

• Brand Name: Model 7A
• Primary DI: 00856233005110
• Version / Model: 7A/Mod 3 Interface cable
• Catalog Number: 0406
• Company Name: CARDIOCOMMAND, INC.
• Labeler DUNS: 800214827
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-03
• Public Version: 4
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: bec2048b-1022-4a6c-a715-6fa576a76189

Device Description

Interface cable between 7A Stimulator and Model 3 preamplifier.

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
36046	External pacemaker, transoesophageal pacing	A device designed to generate electrical cardiac pacing impulses from an external pulse generator (EPG), located outside the body, and transmit them to the heart via its leads that are placed in the oesophagus. The device is used for temporary stimulation of the heart.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856233005110	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P860008	018
P860008	022