ClearTone Doppler

GUDID 00888937001648

Display with 3 MHz Fetal Probe - Rechargeable

Coopersurgical, Inc.

Foetal Doppler system

• Primary Device ID: 00888937001648
• NIH Device Record Key: b663cb23-6146-4302-a62a-28785fa861fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearTone Doppler
• Version Model Number: CT250R-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	00888937001648 [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: 2016-07-20

On-Brand Devices [ClearTone Doppler]

• 00888937001716: 2 MHz Waterproof Fetal Probe
• 00888937001709: 8 MHz Vascular Probe
• 00888937001693: 5 MHz Vascular Probe
• 00888937001686: 3 MHz Fetal Probe
• 00888937001679: 2 MHz Fetal Probe
• 00888937001662: Display with 8 MHz Vascular Probe - Rechargeable
• 00888937001655: Display with 5 MHz Vascular Probe - Rechargeable
• 00888937001648: Display with 3 MHz Fetal Probe - Rechargeable
• 00888937001631: Display with 2 MHz Waterproof Fetal Probe - Rechargeable
• 00888937001624: Display with 2 MHz Fetal Probe - Rechargeable
• 00888937001617: Display with 8 MHz Vascular Probe
• 00888937001600: Display with 5 MHz Vascular Probe
• 00888937001594: Display with 3 MHz Fetal Probe
• 00888937001587: Display with 2 MHz Waterproof Fetal Probe
• 00888937001570: Display with 2 MHz Fetal Probe
• 00888937001563: Display
• 00888937001556: Non-Display with 8 MHz Vascular Probe - Rechargeable
• 00888937001549: Non-Display with 5 MHz Vascular Probe - Rechargeable
• 00888937001532: Non-Display with 3 MHz Fetal Probe - Rechargeable
• 00888937001525: Non-Display with 2 MHz Waterproof Fetal Probe - Rechargeable
• 00888937001518: Non-Display with 2 MHz Fetal Probe - Rechargeable
• 00888937001501: Non-Display with 8 MHz Vascular Probe
• 00888937001495: Non-Display with 5 MHz Vascular Probe
• 00888937001488: Non-Display with 3 MHz Fetal Probe
• 00888937001471: Non-Display with 2MHz Waterproof Fetal Probe
• 00888937001464: Non-Display with 2 MHz Fetal Probe