AccessGUDID - DEVICE: PORTRAIT SBT01 (00195278120014)

GUDID

Device Identifier (DI) Information

Brand Name: PORTRAIT SBT01
Version or Model: SBT01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2096442-001
Company Name: GE Healthcare Finland Oy

Primary DI Number: 00195278120014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 401966697 *Terms of Use

Device Description: SENSOR BATTERY 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?
65828	Multiple vital physiological parameter monitoring system transceiver	An electrically-powered device intended to receive data relating to multiple vital physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)] from an appropriate sensor, and wirelessly transmit the data to a parent device (e.g., monitor and/or an off-the-shelf computer/tablet) with appropriate software installed; it may in addition be intended to provide electrical energy to the connected probe/electrode.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZQ	Monitor, breathing frequency
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)
DRG	TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
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
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ed1a6f9-e020-4401-89a2-95cf74cd58c7
Public Version Date: September 20, 2023
Public Version Number: 1
DI Record Publish Date: September 12, 2023