KermaX-plus

Basic Information

• Brand Name: KermaX-plus
• Primary DI: EIBA1202100
• Version / Model: 1
• Catalog Number: 120-210
• Company Name: IBA Dosimetry GmbH
• Labeler DUNS: 332599307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-17
• Public Version: 2
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 6a823dc6-adfd-4b10-8a58-1db99ef568b7

Device Description

KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.

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: Yes
• 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
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	892.1940	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38385	Diagnostic x-ray system quality assurance device	An instrument intended to be used to assess the performance of diagnostic x-ray equipment for quality assurance (QA) purposes; it is typically intended to measure, display, and record one or more x-ray parameter(s) [e.g., kVp, mAs, dose, exposure time]. It may be placed in the field of view and/or be connected to the x-ray equipment, and may have various forms (e.g., handheld or desktop unit with sensor and dedicated software).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EIBA1202101	HIBCC		1	In Commercial Distribution
Primary	EIBA1202100	HIBCC

Customer Contacts

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