bk3000, bk3500 & bk5000 Ultrasound System

GUDID 05704916000264

Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnos

Bk Medical ApS

General-purpose ultrasound imaging system

• Primary Device ID: 05704916000264
• NIH Device Record Key: 71faf51b-4bae-4c4c-af12-be821d5d6da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bk3000, bk3500 & bk5000 Ultrasound System
• Version Model Number: 2300
• 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
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916000264 [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

• 05704916000288 - Foot Switch: 2025-05-15 USB Foot Switch for bk3000, bk5000, bkActiv
• 05704916000318 - Wireless Remote Control: 2025-05-15 Wireless Remote Control for bk3000 and bk5000
• 05704916001612 - Wireless Remote Control: 2025-05-15 Wireless Remote Control for bkActiv
• 05704916000974 - Disposable Needle Guide: 2025-05-08 Disposable needle guide for 5C1e (9085)
• 05704916001346 - Water Standoff Collar: 2025-05-08 Water Standoff Collar for 20R3 / 9052 Transducer
• 05704916001353 - Rectosigmoidoscope with Obturator: 2025-05-08 Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052
• 05704916001360 - Rectosigmoidoscope with Obturator: 2025-05-08 Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052
• 05704916001537 - Dummy Channel Bracket: 2025-05-08 Dummy Channel Bracket for 8808e, 8818