AccessGUDID - DEVICE: Invenia (00195278756237)

GUDID

Device Identifier (DI) Information

Brand Name: Invenia
Version or Model: ABUS R2.5 Premium
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H5023S1-H5013S1
Company Name: Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Primary DI Number: 00195278756237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119309548 *Terms of Use

Device Description: Invenia ABUS Premium

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PAA	Automated Breast Ultrasound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P110006	011

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 67abf4c8-342d-4eed-b3b0-71598e2073d2
Public Version Date: March 12, 2025
Public Version Number: 1
DI Record Publish Date: March 04, 2025