14L3e Transducer 9086

GUDID 05704916000363

Pediatric, Small Organ (small parts), Musculoskeletal (conventional), Musculoskeletal (superficial), Peripheral vessel (Peripheral vascular), Elastogr

Bk Medical ApS

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 05704916000363
• NIH Device Record Key: ac4e4b9a-bb76-44f8-a7e6-98ae584c123d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 14L3e Transducer
• Version Model Number: 9086
• Catalog Number: 9086
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916000363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173569

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-13
• Device Publish Date: 2018-07-12

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• 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