HERA

Basic Information

• Brand Name: HERA
• Primary DI: 04250289512909
• Version / Model: REF.HER-1000
• Company Name: Aesku.Diagnostics GmbH & Co. KG
• Labeler DUNS: 341714388
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-20
• Public Version: 1
• Public Version Date: 2023-07-28
• Public Version Status: New
• Public Device Record Key: 0b4afa88-3bca-4a1d-913d-08c533826797

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: No
• 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
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	862.2100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65603	Clinical management support software IVD	An in vitro diagnostic application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic, laboratory results) and returning clinical care information (e.g., reports, pedigree diagrams, reminders, post-therapy prognosis/risk score, suggested pharmaceutical dosage) to a healthcare professional responsible for patient care. Otherwise known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application. It is not primarily intended to manage diagnostic/patient images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250289512909	GS1