FDP Probe FDP-20

GUDID 00894912002869

Flat PW Doppler probe, 20 MHz

KOVEN TECHNOLOGY, INC.

Noninvasive vascular ultrasound system probe

• Primary Device ID: 00894912002869
• NIH Device Record Key: 1d33f175-1ac1-43d8-bbf5-590108cf9ecc
• Commercial Distribution Discontinuation: 2018-05-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FDP Probe
• Version Model Number: FDP-20
• Catalog Number: FDP-20
• Company DUNS: 069261402
• Company Name: KOVEN TECHNOLOGY, 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

Customer Support Contacts

• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894912002869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935994

FDA Product Code

• JAF: Monitor, Ultrasonic, Nonfetal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-11-03
• Device Publish Date: 2016-06-17

On-Brand Devices [FDP Probe]

• 00894912002869: Flat PW Doppler probe, 20 MHz
• 00894912002548: Flat PW Doppler probe, 8 MHz
• 00894912002531: Flat PW Doppler probe, 10 MHz