NA

Basic Information

• Brand Name: NA
• Primary DI: 00195278002730
• Version / Model: ML4-20VN-D
• Catalog Number: H44901AU
• Company Name: GE PARALLEL DESIGN, INC.
• Labeler DUNS: 623906971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-18
• Public Version: 1
• Public Version Date: 2021-11-26
• Public Version Status: New
• Public Device Record Key: fd978af2-6f3e-41e3-995c-c389d58a3a03

Device Description

ML4-20VN-D

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: No
• 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
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2
IYN	System, imaging, pulsed doppler, ultrasonic	Radiology	892.1550	2
IYO	System, imaging, pulsed echo, ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40768	Extracorporeal ultrasound imaging transducer, hand-held	A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195278002730	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211524	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius