AcuNav 8F Ultrasound Catheter

GUDID 04056869001029

SIEMENS MEDICAL SOLUTIONS USA, INC.

Intracardiac ultrasound imaging catheter, steerable, single-use

• Primary Device ID: 04056869001029
• NIH Device Record Key: 78f071d7-dda9-425b-a35e-034361b9682b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuNav 8F Ultrasound Catheter
• Version Model Number: 10135936
• Company DUNS: 136120750
• Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869001029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042593
• Premarket Notification: K071234

FDA Product Code

• OBJ: Catheter, ultrasound, intravascular

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: 2019-03-21
• Device Publish Date: 2016-09-24

Devices Manufactured by SIEMENS MEDICAL SOLUTIONS USA, INC.

• 04056869990415 - 11M2 Transducer: 2024-12-05
• 04068151010022 - HLX Transducer: 2024-12-05
• 04068151009477 - Scenium: 2024-09-16
• 04068151027013 - MI View&GO: 2024-09-16
• 04068151012477 - ACUSON Origin ICE Diagnostic Ultrasound System: 2024-08-30
• 04056869997445 - AcuNav Lumos 4D ICE catheter: 2024-07-29
• 04068151001303 - ACUSON P500 ICE Ultrasound System: 2024-07-09
• 04056869950747 - 6C1 HD Transducer: 2024-05-16