3CPM Company, Inc

GUDID 00864359000216

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

3CPM CO., INC.

Electrocardiograph, professional, single-channel Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system Myoelectric gastrointestinal motility analysis system

• Primary Device ID: 00864359000216
• NIH Device Record Key: 00591be2-b35e-4b62-8066-727e579f35c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3CPM Company, Inc
• Version Model Number: 2.09e
• Company DUNS: 022772521
• Company Name: 3CPM CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864359000216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN990005

FDA Product Code

• MYE: System,Electrogastrography(Egg)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

On-Brand Devices [3CPM Company, Inc]

• 00864359000223: 3CPM Company Electrogastrogram Research/Waterload platform Unit. Device uses ECG-like technology
• 00864359000216: 3CPM Company Electrogastrogram Research platform Unit. Device uses ECG-like technology to captur
• 00864359000209: The 3CPM Company, Inc Electrogastrogram Waterload platform Unit. Device uses ECG-like technology