AccessGUDID - DEVICE: EPIQ 7 Diagnostic Ultrasound System Circular Edition (00884838125650)

GUDID

Device Identifier (DI) Information

Brand Name: EPIQ 7 Diagnostic Ultrasound System Circular Edition
Version or Model: 795117
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Philips Ultrasound LLC

Primary DI Number: 00884838125650
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063377717 *Terms of Use

Device Description: VM11.0 update

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
OBJ	Catheter, Ultrasound, Intravascular
QIH	Automated Radiological Image Processing Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233545	000
K233788	000
K240850	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e04d74a2-ebc2-4818-8b29-c50969fbf3b6
Public Version Date: June 11, 2024
Public Version Number: 1
DI Record Publish Date: June 03, 2024