Invenia

Basic Information

• Brand Name: Invenia
• Primary DI: 00195278756237
• Version / Model: ABUS R2.5 Premium
• Catalog Number: H5023S1-H5013S1
• Company Name: GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
• Labeler DUNS: 119309548
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-04
• Public Version: 2
• Public Version Date: 2026-02-18
• Public Version Status: Update
• Public Device Record Key: 67abf4c8-342d-4eed-b3b0-71598e2073d2

Device Description

Invenia ABUS Premium

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
PAA	Automated Breast Ultrasound	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
40764	Breast ultrasound imaging system	An assembly of electrically-powered devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. It typically includes software packages that support a variety of static or real-time breast specific imaging used primarily for oncology. It will generate ultrasound pulses, direct them to the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195278756237	GS1

Premarket Submissions

Submission Number	Supplement Number
P110006	011

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Storing condition Altitude: 0 to 5000 meters
• Type: Special Storage Condition, Specify
• Special Conditions: Operating condition Altitude: 0 to 3000 meters