Flex Focus Ultrasound System

GUDID 05704916001025

Ultrasound scanner 1202 and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode

Bk Medical ApS

General-purpose ultrasound imaging system

• Primary Device ID: 05704916001025
• NIH Device Record Key: 5c6b7456-9a73-42b9-bc57-9d80cad121ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex Focus Ultrasound System
• Version Model Number: 1202
• Company DUNS: 310093901
• Company Name: Bk Medical ApS
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4544528100
• Email: info@bkultrasound.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916001025 [Primary]

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2018-05-23
• Device Publish Date: 2016-09-17

Devices Manufactured by Bk Medical ApS

• 05704916001711 - I13C3fx Transducer: 2023-06-22 Tracked Laparoscopic Intraoperative Transducer -with build-in tracking internal sensor
• 05704916001667 - Non-implantable needle guide, single-use: 2022-12-15 Disposable 18g Transperineal Needle Guide
• 05704916001698 - Non-implantable needle guide, single-use: 2022-12-15 Non-implantable needle guide, single-use
• 05704916001599 - Rob12C4: 2022-05-31 The Rob12C4 drop-in transducer enables unique access to complex organs and difficult-to-access anatomy during robotic-assisted p
• 05704916000240 - I13C3f Transducer: 2020-04-03 Intraoperative
• 05704916001131 - N20P6 Transducer: 2020-04-03 High resolution, mini footprint, Intraoperative (neuro) imaging
• 05704916001315 - I12C5 transducer: 2020-04-03 Peripheral vessel (vascular), Pediatric, Small organs (small parts), Musculoskeletal (conventional and superficial)
• 05704916001407 - Non-implantable, needle guide, reusable: 2019-12-23 Reusable Transperineal Needle Guide