DiaMon Fixation 7167

GUDID 04260493311618

DiaMon WITHOUT Probes, bilateral with probe holders for screw topped probes and operating instructions

Compumedics Germany GmbH

Noninvasive vascular ultrasound system probe

• Primary Device ID: 04260493311618
• NIH Device Record Key: 14b739ab-264f-43d4-829f-e8b4fefbaf09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiaMon Fixation
• Version Model Number: FIx_DiaMon_7167
• Catalog Number: 7167
• Company DUNS: 344791632
• Company Name: Compumedics Germany GmbH
• 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: false
• Manufacturing Date: false
• 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: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260493311618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051085

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: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [DiaMon Fixation]

• 04260493313186: Head pad set for DiaMon (set of 4 pcs)
• 04260493312202: DiaMon Set for handheld probes, bilateral with 2 x 2 MHz probes, handheld (2.9 meter cable)
• 04260493312189: DiaMon Set for handheld probes, bilateral with 2 x 1 MHz probes, handheld (2.9 meter cable)
• 04260493312172: DiaMon Set for handheld probes, bilateral with 2 x 1 MHz probes, handheld (2 meter cable)
• 04260493312141: DiaMon Set for handheld probes, unilateral with 2 MHz probe, handheld (2.9 meter cable)
• 04260493312134: DiaMon Set for handheld probes, unilateral with 2 MHz probe, handheld (2 meter cable)
• 04260493312127: DiaMon Set for handheld probes, unilateral with 1 MHz probe, handheld (2.9 meter cable)
• 04260493312110: DiaMon Set for handheld probes, unilateral with 1 MHz probe, handheld (2 meter cable)
• 04260493312103: Fixation for handheld probes for DiaMon
• 04260493312073: DiaMon Set for monitoring probes, unilateral with 1 MHz probe, click&stay
• 04260493312042: DiaMon Set for monitoring probes, unilateral with 1 MHz probe, screw topped
• 04260493311731: DiaMon Set for monitoring probes, bilateral with 2 x 1 MHz probes, click&stay
• 04260493311724: DiaMon Set for monitoring probes, bilateral with 2 x 1 MHz probes screw topped
• 04260493311656: DiaMon Set for monitoring probes, bilateral with 2 x 2 MHz probes screw topped
• 04260493311649: DiaMon Set for monitoring probes, bilateral with 2 x 2 MHz probes, click&stay
• 04260493311632: DiaMon Set for monitoring probes, unilateral with 2 MHz probe, screw topped
• 04260493311625: DiaMon Set for monitoring probes, unilateral with 2 MHz probe, click&stay
• 04260493311618: DiaMon WITHOUT Probes, bilateral with probe holders for screw topped probes and operating instru
• 04260493311601: DiaMon WITHOUT Probes, bilateral with probe holders for click&stay probes and operating instruct
• 04260493312196: DiaMon Set for handheld probes, bilateral with 2 x 2 MHz probes, handheld (2 meter cable)