3.0 MHz Early Fetal Probe

GUDID 00888937001365

For TRIA II Dopplers

Coopersurgical, Inc.

Foetal Doppler system probe

• Primary Device ID: 00888937001365
• NIH Device Record Key: 80f675ce-4dde-45f4-91ad-0ea323902c13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.0 MHz Early Fetal Probe
• Version Model Number: TSP-3
• 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	00888937001365 [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

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