Curved Array Transducer

GUDID 05704916000554

Abdominal, Obstetrics, Fetal

Bk Medical ApS

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 05704916000554
• NIH Device Record Key: fdc16ba9-8eb3-40e7-bdc9-d6834bed4057
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curved Array Transducer
• Version Model Number: 8820e
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916000554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043524

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [Curved Array Transducer]

• 05704916000608: Abdominal, Obstetrics, Fetal, Pediatrics
• 05704916000578: Abdominal
• 05704916000554: Abdominal, Obstetrics, Fetal