TRIA II Display Doppler

GUDID 00888937001303

With 8.0 MHz Sterilizable Vascular Probe

Coopersurgical, Inc.

Noninvasive vascular ultrasound system, battery-powered

• Primary Device ID: 00888937001303
• NIH Device Record Key: 25a07fbb-22b3-417b-85dc-1333a893ab73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIA II Display Doppler
• Version Model Number: T337-DS
• 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: 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	00888937001303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024197

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: 2016-03-31

On-Brand Devices [TRIA II Display Doppler]

• 00888937001334: With 2.0 MHz Obstetrical Probe
• 00888937001303: With 8.0 MHz Sterilizable Vascular Probe
• 00888937001297: With 8.0 MHz Vascular Probe
• 00888937001273: With 2.0 MHz Waterproof Obstetrical Probe
• 00888937001266: With 5.0 MHz Vascular Probe
• 00888937001242: With 3.0 MHz Fetal Probe