Model: 600000030284
DI: 04719873000524
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e3170451-6b2a-45e1-a6de-1b3ace572b7a
Distribution Status:
In Commercial Distribution
DUNS Number:
656079068
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04719873000524
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40761
Name: General-purpose ultrasound imaging system
Definition:
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.
FDA Product Codes
IYO
System, Imaging, Pulsed Echo, Ultrasonic
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
ITX
Transducer, Ultrasonic, Diagnostic