Model 3

Basic Information

• Brand Name: Model 3
• Primary DI: 10856233005193
• Version / Model: Re-manufactured, single pack
• Catalog Number: 0104-9999
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 50ec0ccf-2339-4b22-b4db-fb2a09ad6fb2

Device Description

Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals; re-manufactured, (single unit package).

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: Yes
• Has Lot/Batch Number: No
• 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
36719	Electrocardiographic signal amplifier	An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10856233005193	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P860008	018
P860008	022

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 40 – 158 Degrees Fahrenheit