MedaSonics

GUDID 00888937002621

CardioBeat Vascular Doppler with Speaker; without Display; 5MHz

Coopersurgical, Inc.

Noninvasive vascular ultrasound system, battery-powered

• Primary Device ID: 00888937002621
• NIH Device Record Key: 040fab69-d8e5-482d-a0de-31ef5873951a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedaSonics
• Version Model Number: 101-0333-010
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937002621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961116

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, 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: 2016-07-18

On-Brand Devices [MedaSonics]

• 00888937002621: CardioBeat Vascular Doppler with Speaker; without Display; 5MHz
• 00888937002614: First Beat Fetal Doppler with Speaker; without Display
• 00888937002607: CardioBeat Doppler with Stethoscope; 5MHz
• 00888937002591: CardioBeat Doppler with Calc Display, Speaker, 5MHz
• 00888937002584: First Beat Doppler with Headphones
• 00888937002577: First Beat Fetal Doppler with Stethoscope
• 00888937002560: First Beat Fetal Doppler with Calc Display and Speaker
• 00888937002553: BF4B Vascular Doppler with Stethocope; 5 MHz
• 00888937002546: Versatone P83 Probe; 8MHz; 2.5cm
• 00888937002539: Versatone P82 Probe; 8MHz; 11.5cm
• 00888937002522: Versatone P81 Probe; 2.4MHz; 3.3cm
• 00888937002515: Versatone D8 Doppler 220V AC
• 00888937002508: Versatone D8 Doppler 115V AC