BT5M05S8A BT5M05S8A

GUDID 00894912002333

5 MHz straight cable clinic CW Doppler probe.

KOVEN TECHNOLOGY, INC.

Noninvasive vascular ultrasound system probe

• Primary Device ID: 00894912002333
• NIH Device Record Key: 9927175f-4e2f-4f15-8ef1-99b47e085033
• Commercial Distribution Discontinuation: 2016-07-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BT5M05S8A
• Version Model Number: BT5M05S8A
• Catalog Number: BT5M05S8A
• 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	00894912002333 [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

On-Brand Devices [BT5M05S8A]

• 00894912002975: 5 MHz straight cable clinic CW Doppler probe.
• 00894912002333: 5 MHz straight cable clinic CW Doppler probe.