AccessGUDID - DEVICE: Portrait CSS01 (00195278341129)

GUDID

Device Identifier (DI) Information

Brand Name: Portrait CSS01
Version or Model: CSS01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5870857
Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Primary DI Number: 00195278341129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006580799 *Terms of Use

Device Description: PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
44101	Bedside information system application software	An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the provision and utilization of administrative and clinical information at the patient's bedside. It is typically supplied for installation into a dedicated information system used at the patient's bedside or existing mainframe or decentralized computers/networks.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)
DRG	TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
BZQ	Monitor, breathing frequency
DQA	Oximeter
MSX	System, network and communication, physiological monitors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230626	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: 0fd149d2-0ddd-4595-8b55-43d2bcaabd51
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 01, 2023