Model 3 0104

GUDID 00856233005189

Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals, (unpackaged unit).

CARDIOCOMMAND, INC.

Electrocardiographic signal amplifier

• Primary Device ID: 00856233005189
• NIH Device Record Key: c3f54fc1-84e5-4824-af24-6e349516b4c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 3
• Version Model Number: Unpackaged
• Catalog Number: 0104
• Company DUNS: 800214827
• Company Name: CARDIOCOMMAND, 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 231-6370
• Email: cconley@CardioCommand.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856233005189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860008

FDA Product Code

• LPA: System, Esophageal Pacing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-04-03

On-Brand Devices [Model 3]

• 00856233005196: Amplification and signal processing module designed to interface with CardioCommand esophageal c
• 00856233005189: Amplification and signal processing module designed to interface with CardioCommand esophageal c