3CPM Company, Inc.

Basic Information

• Brand Name: 3CPM Company, Inc.
• Primary DI: 00864359000261
• Version / Model: 1
• Company Name: 3CPM CO., INC.
• Labeler DUNS: 022772521
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-18
• Public Version: 2
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: c1e993a2-547b-42b8-a6e2-29b98173345b

Device Description

6' leads for use with EGG system

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• 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
MYE	System, Electrogastrography (Egg)	Gastroenterology, Urology	876.1735	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64488	Myoelectric gastrointestinal motility analysis system	An assembly of devices designed to non-invasively measure gastric myoelectrical activity to assist in the diagnosis and evaluation of gastrointestinal motility disorders (e.g., tachygastria, bradygastria, functional outlet obstruction). The assembly includes an electrically-powered control unit with attached noninvasive skin myoelectric sensor(s), connected to a computing device for analysis and display. Otherwise known as an electrogastrogram, it is typically intended as an alternative to invasive manometry.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864359000261	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN990005	000