N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10841898123245
• Version / Model: N/A
• Catalog Number: 10438577
• Company Name: INNOVATIVE HEALTH LLC
• Labeler DUNS: 015575953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-12
• Public Version: 2
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: 8688d2b2-8e1b-4662-9662-ba3d08debc4c

Device Description

SoundStar eco Diagnostic Ultrasound Catheter, 10F

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61811	Intracardiac ultrasound imaging catheter, steerable, reprocessed	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 an ultrasound system for image transmission/display. This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841898123245	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170474	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -18 – 45 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -18 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity