BF8M15S8A BF8M15S8A

GUDID 00894912002296

8 MHz flat clinic CW Doppler probe.

KOVEN TECHNOLOGY, INC.

Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe

• Primary Device ID: 00894912002296
• NIH Device Record Key: 10fbb03c-5c65-4094-976b-a929ca9cffe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BF8M15S8A
• Version Model Number: BF8M15S8A
• Catalog Number: BF8M15S8A
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894912002296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934638

FDA Product Code

• JOP: Transducer, 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: 4
• Public Version Date: 2023-11-03
• Device Publish Date: 2016-03-10

Devices Manufactured by KOVEN TECHNOLOGY, INC.

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• 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: 2023-11-038 MHz flat clinic CW Doppler probe.
• 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.