AcuNav Volume ICE Catheter

Basic Information

• Brand Name: AcuNav Volume ICE Catheter
• Primary DI: 04056869275079
• Version / Model: 11508800
• Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Labeler DUNS: 804722783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-04
• Public Version: 2
• Public Version Date: 2023-06-23
• Public Version Status: Update
• Public Device Record Key: 9ac46340-01a3-47af-a198-e18c16fa404c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBJ	Catheter, ultrasound, intravascular	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42584	Intracardiac ultrasound imaging catheter, steerable, single-use	A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056869275079	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K163478	000
K203726	000
K212959	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12.5	French
Device Size Text, specify

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius