Monica

GUDID 15060433670104

Monica Interface CTG Cable - GE Corometrics FECG green rectangular connector

MONICA HEALTHCARE LIMITED

Foetal cardiac monitor

• Primary Device ID: 15060433670104
• NIH Device Record Key: cee2288c-0e19-447f-9364-2d01551e97b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monica
• Version Model Number: 105-PT-103
• Company DUNS: 346332666
• Company Name: MONICA HEALTHCARE LIMITED
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060433670107 [Primary]
GS1	15060433670104 [Package]; Contains: 05060433670107; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• OSP: Uterine Electromyographic Monitor

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: 2018-09-25
• Device Publish Date: 2016-09-12

On-Brand Devices [Monica]

• 15060433670135: Monica Interface CTG Cable - GE Corometrics UA round white connector
• 15060433670111: Monica Interface CTG Cable - GE Corometrics MECG round green connector
• 15060433670104: Monica Interface CTG Cable - GE Corometrics FECG green rectangular connector
• 15060433670098: Monica Interface CTG Cable - GE Corometrics FECG round black connector