ES101EX ES101EX-2

GUDID 00894912002074

Fetal Echosounder Doppler.

KOVEN TECHNOLOGY, INC.

Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system

• Primary Device ID: 00894912002074
• NIH Device Record Key: e3beb1be-3682-40a4-ba62-3caae10c9276
• Commercial Distribution Discontinuation: 2021-02-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ES101EX
• Version Model Number: ES101EX-2
• Catalog Number: ES101EX-2
• Company DUNS: 069261402
• Company Name: KOVEN TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894912002074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031504

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: 4
• Public Version Date: 2021-02-04
• Device Publish Date: 2016-02-24

Devices Manufactured by KOVEN TECHNOLOGY, INC.

• 00894912002043 - BiDop 3: 2023-11-03 Bidirectional Doppler with waveform display.
• 00894912002197 - PG-21: 2023-11-03 PPG probe module.
• 00894912002203 - PGV-20: 2023-11-03 PPG and Pulse Volume combo module for Smartdops.
• 00894912002296 - BF8M15S8A: 2023-11-03 8 MHz flat clinic CW Doppler probe.
• 00894912002302 - BT10M5S8A: 2023-11-03 10 MHz straight cable clinic CW Doppler probe.
• 00894912002319 - BT10M5S8C: 2023-11-03 10 MHz curly cable clinic CW Doppler probe.
• 00894912002333 - BT5M05S8A: 2023-11-03 5 MHz straight cable clinic CW Doppler probe.
• 00894912002340 - BT5M05S8C: 2023-11-03 5 MHz curly cable clinic CW Doppler probe.