3CPM Company, Inc.

GUDID 00864359000278

Disposable Electrode and Lead Set for use with 3CPM EGG System, 40pk

3CPM CO., INC.

Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel 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: 00864359000278
• NIH Device Record Key: 2aae4f65-10eb-41e0-8d19-c6a58c482c21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3CPM Company, Inc.
• Version Model Number: 1
• 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: true
• 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	00864359000278 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-26
• Device Publish Date: 2020-08-18

On-Brand Devices [3CPM Company, Inc.]

• 00864359000292: 3CPM EGGSAS Research/Waterload Interface (Software Only)
• 00864359000285: 3CPM EGGSAS Waterload Interface (Software Only)
• 00864359000278: Disposable Electrode and Lead Set for use with 3CPM EGG System, 40pk
• 00864359000261: 6' leads for use with EGG system
• 00864359000254: Respiratory Belt for 3CPM Electrogastrography system
• 00864359000247: 3CPM EGGSAS Research Interface (Software Only)
• 00864359000230: Human Interface Device