AccessGUDID - DEVICE: LOGIQ (00195278869616)

GUDID

Device Identifier (DI) Information

Brand Name: LOGIQ
Version or Model: E10-V R4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

Primary DI Number: 00195278869616
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078863378 *Terms of Use

Device Description: LOGIQ E10-V R4 Console

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
40761	General-purpose ultrasound imaging system	A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYN	System, Imaging, Pulsed Doppler, Ultrasonic
IYO	System, Imaging, Pulsed Echo, Ultrasonic
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 -20 and 60 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Height: 1300 Millimeter
Length: 901 Millimeter
Width: 585 Millimeter

Device Record Status

Public Device Record Key: 43ddec2c-1d3f-4ffc-93ec-b99485ff4ccc
Public Version Date: April 24, 2025
Public Version Number: 2
DI Record Publish Date: December 06, 2024