ClearTone Doppler

GUDID 00888937001556

Non-Display with 8 MHz Vascular Probe - Rechargeable

Coopersurgical, Inc.

Noninvasive vascular ultrasound system, battery-powered Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system

• Primary Device ID: 00888937001556
• NIH Device Record Key: 9906870c-e57c-4682-920b-b18ba961b496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearTone Doppler
• Version Model Number: CT150R-8
• 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	00888937001556 [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: 2016-07-20

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