I12C5 transducer

GUDID 05704916001315

Peripheral vessel (vascular), Pediatric, Small organs (small parts), Musculoskeletal (conventional and superficial)

Bk Medical ApS

Surgical ultrasound imaging transducer

• Primary Device ID: 05704916001315
• NIH Device Record Key: 1c0a6611-3e86-4623-96de-9e5bf178cea1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I12C5 transducer
• Version Model Number: 9034
• 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: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• 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: 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916001315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180737

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

[05704916001315]

Hydrogen Peroxide;Peracetic Acid

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-03
• Device Publish Date: 2020-03-26

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• 05704916000318 - Wireless Remote Control: 2025-05-15 Wireless Remote Control for bk3000 and bk5000
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• 05704916001346 - Water Standoff Collar: 2025-05-08 Water Standoff Collar for 20R3 / 9052 Transducer
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• 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