Frontier X Plus

GUDID 08908013617128

Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation.

FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED

Electrocardiographic long-term ambulatory recording analyser

• Primary Device ID: 08908013617128
• NIH Device Record Key: 203a214f-0371-4d9c-b9a1-8afd250bf503
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Frontier X Plus
• Version Model Number: Frontier X Plus
• Company DUNS: 860277087
• Company Name: FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com
• Phone: 15128817266
• Email: support@fourthfrontier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908013617128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240794

FDA Product Code

• MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

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: 2025-02-17
• Device Publish Date: 2025-02-07