NOMAD MD™ handheld X-ray system

Basic Information

• Brand Name: NOMAD MD™ handheld X-ray system
• Primary DI: EKAV085004700
• Version / Model: 0.850.0470
• Catalog Number: FP 0204
• Company Name: ARIBEX, INC.
• Labeler DUNS: 169065526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c15375dc-422a-43d2-8bdd-5d3ea4112132

Device Description

Handheld x-ray

Device Characteristics

• Single Use: No
• 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: 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
IZL	System, x-ray, mobile	Radiology	892.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37607	Diagnostic x-ray system generator, hand-held	An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a hand-held x-ray system, e.g., a system that is held during operation. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer and inverter generator designs. A hand-held x-ray system generators typically comprises a control assembly (console) and high voltage transformer assembly, but can also be a mono-tank generator design.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKAV085004700	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140723	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius