AccessGUDID - DEVICE: Versana (00195278690401)

GUDID

Device Identifier (DI) Information

Brand Name: Versana
Version or Model: Premier LOTUS 4PP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GE Medical Systems (China) Co.,Ltd.

Primary DI Number: 00195278690401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654658731 *Terms of Use

Device Description: Magna R3 LOTUS 4pp Basic 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
IYO	System, imaging, pulsed echo, ultrasonic
ITX	Transducer, ultrasonic, diagnostic
IYN	System, imaging, pulsed doppler, ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242005	000

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
Special Storage Condition, Specify: Handing environment temperature from 10 degree C to 30 degree C with battery
Special Storage Condition, Specify: Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d8279fa-c037-488c-9f22-cc6e845f4930
Public Version Date: November 28, 2024
Public Version Number: 1
DI Record Publish Date: November 20, 2024