AccessGUDID - DEVICE: PORTRAIT HUB01 (00195278093998)

GUDID

Device Identifier (DI) Information

Brand Name: PORTRAIT HUB01
Version or Model: HUB01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2096437-001
Company Name: GE Healthcare Finland Oy

Primary DI Number: 00195278093998
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 401966697 *Terms of Use

Device Description: HUB, AMBULATORY HUB DEVICE ASSEMBLY

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?
65831	Wearable multiple vital physiological parameter monitor	A portable assembly of electrically-powered devices intended to be worn by an ambulatory patient in a healthcare setting for intermittent assessment or continuous monitoring of several vital physiologic parameters [e.g., electrocardiogram (ECG), respiration rate, haemoglobin oxygen saturation (SpO2)] while allowing freedom of movement (e.g., in step-down care areas). It includes processing hardware to be used with dedicated software (that may be pre-installed); the sensors, probes, and/or electrodes are not included. It typically incorporates a monitoring screen and may allow communication with a stationary device (e.g., off-the shelf computer).	Active	false

FDA Product Code

[?]

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

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
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53fb7e39-add0-48c8-b76c-abae470336c4
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 01, 2023