AccessGUDID - DEVICE: 3CPM Company, Inc (00864359000223)

GUDID

Device Identifier (DI) Information

Brand Name: 3CPM Company, Inc
Version or Model: 2.09e
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 3CPM CO., INC.

Primary DI Number: 00864359000223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022772521 *Terms of Use

Device Description: 3CPM Company Electrogastrogram Research/Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
11413	Electrocardiograph, professional, single-channel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYE	System,Electrogastrography(Egg)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN990005	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e73eb35-d54e-4497-ba2d-d4964be276d1
Public Version Date: March 10, 2021
Public Version Number: 6
DI Record Publish Date: September 27, 2016