BladderScan®

Basic Information

• Brand Name: BladderScan®
• Primary DI: 00879123008145
• Version / Model: i10™
• Catalog Number: 0620-1083
• Company Name: VERATHON INC
• Labeler DUNS: 130598584
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-21
• Public Version: 1
• Public Version Date: 2021-05-31
• Public Version Status: New
• Public Device Record Key: 3e521211-8c20-4e7b-99b5-e50fb966e396

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38395	Ultrasound system quality assurance device	An instrument used for quality assurance (QA) purposes to check the calibration and performance of systems that produce ultrasound waves used for diagnostic or therapeutic applications. This includes a variety of instruments used to measure parameters associated with beam production, beam quality, image quality and other system performance parameters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10879123008142	GS1	Case	1	In Commercial Distribution
Primary	00879123008145	GS1

Premarket Submissions

Submission Number	Supplement Number
K172356	000