TRIA II Doppler

GUDID 00888937001327

With 2.0 MHz Obstetrical Probe

Coopersurgical, Inc.

Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system

• Primary Device ID: 00888937001327
• NIH Device Record Key: a2112172-5a66-4f8c-bcd3-379738c35cc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIA II Doppler
• Version Model Number: T345
• 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	00888937001327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024197

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

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 Doppler]

• 00888937001327: With 2.0 MHz Obstetrical Probe
• 00888937001310: With 8.0 MHz Sterilizable Vascular Probe
• 00888937001280: With 8.0 MHz Vascular Probe
• 00888937001259: With 5.0 MHz Vascular Probe
• 00888937001235: With 3.0 MHz Fetal Probe