Uscan Mobile Stand

Basic Information

• Brand Name: Uscan Mobile Stand
• Primary DI: 09353278000205
• Version / Model: P006024
• Company Name: ECHONOUS, INC.
• Labeler DUNS: 080481089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-11
• Public Version: 1
• Public Version Date: 2019-11-19
• Public Version Status: New
• Public Device Record Key: 33e3aa8a-d6ba-4d64-93dc-f6ffd3d4734c

Device Description

Radiological imaging system transport kit

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
61658	Radiological imaging system transport kit	A collection of devices intended to support the transport and utilization of a portable or mobile radiological imaging system (e.g., a portable/mobile ultrasound system). It typically consists of portable or mobile containers, a stand, and sometimes items such as a kickstand, tripod, and holder for mounting/securing mobile system components (e.g. imaging display unit, probes).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09353278000205	GS1

Premarket Submissions

Submission Number	Supplement Number
K181574	000