AccessGUDID - DEVICE: Portrait CVA01 (00195278330413)

GUDID

Device Identifier (DI) Information

Brand Name: Portrait CVA01
Version or Model: CVA01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5863721
Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Primary DI Number: 00195278330413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006580799 *Terms of Use

Device Description: PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2

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?
65832	Wireless patient monitor/sensor reporting software, professional-only	A software program intended to be installed on an off-the-shelf, computerized device (e.g., desktop computer, tablet) and used by a healthcare professional in a clinical/care setting to receive data from a noninvasive, patient-worn, wireless monitor/sensor. It is not dedicated to bedside monitoring.	Active	false

FDA Product Code

[?]

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

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: 723bdc41-ae9b-436d-a932-bc93dd90fc78
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 01, 2023