AccessGUDID - DEVICE: ACUSON Sequoia Select Diagnostic Ultrasound System (04056869981062)

GUDID

Device Identifier (DI) Information

Brand Name: ACUSON Sequoia Select Diagnostic Ultrasound System
Version or Model: 11658635
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.

Primary DI Number: 04056869981062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 804722783 *Terms of Use

Device Description: No description.

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
ITX	Transducer, ultrasonic, diagnostic
IYO	System, imaging, pulsed echo, ultrasonic
IYN	System, imaging, pulsed doppler, ultrasonic
QIH	Automated Radiological Image Processing Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223735	000
K232145	000
K240704	000
K242523	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab739332-17b4-4d8f-a547-77b0da26f5a4
Public Version Date: November 28, 2024
Public Version Number: 4
DI Record Publish Date: April 21, 2023