Trackstar

GUDID 00845717012096

TRACKSTAR DIGITAL ARM BP MONITOR, BLUETOOTH

VERIDIAN HEALTHCARE LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00845717012096
• NIH Device Record Key: 81da0f86-a718-478c-be0b-01158ed3cc4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trackstar
• Version Model Number: 302-2110B
• Company DUNS: 830437997
• Company Name: VERIDIAN HEALTHCARE LLC
• 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: true
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845717012096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241351

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2025-09-23
• Device Publish Date: 2025-09-15

On-Brand Devices [Trackstar]

• 00845717012195: Trackstar Wide-Platform Digital Weight Scale, Bluetooth
• 00845717012102: Trackstar Bluetooth Digital Weight Scale
• 00845717012164: Trackstar Bluetooth Pulse Oximeter
• 00845717012096: TRACKSTAR DIGITAL ARM BP MONITOR, BLUETOOTH