TRIA II

GUDID 00888937011340

Doppler Probe; 5 MHz Interchangeable Model

Coopersurgical, Inc.

Noninvasive vascular ultrasound system probe

• Primary Device ID: 00888937011340
• NIH Device Record Key: db38b029-71ae-4c7f-a7b3-8130af3a15f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIA II
• Version Model Number: P339
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937011340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991441

FDA Product Code

• HEP: Monitor, Blood-Flow, Ultrasonic

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: 2016-07-28

On-Brand Devices [TRIA II]

• 00888937011340: Doppler Probe; 5 MHz Interchangeable Model
• 00888937011333: Doppler Probe; 2 MHz Interchangeable Model