3CPM Company, Inc.

GUDID 00864359000278

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

3CPM CO., INC.

Electrocardiograph, professional, single-channel

• 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