AccessGUDID - DEVICE: PORTRAIT SpO2 P-W01 (00195278264800)

GUDID

Device Identifier (DI) Information

Brand Name: PORTRAIT SpO2 P-W01
Version or Model: P-W01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2096441-001
Company Name: GE Healthcare Finland Oy

Primary DI Number: 00195278264800
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 401966697 *Terms of Use

Device Description: PORTRAIT SpO2 P-W FINAL 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?
65829	Pulse oximeter probe/processor	A photoelectric device designed to be applied externally to a body site (e.g., fingertip) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED), received by a photodetector, and processed to produce the measurements. The measurements are subsequently sent to an appropriate device for display (not included). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter
MSX	System, network and communication, physiological monitors
BZQ	Monitor, breathing frequency
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)
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 Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -30 and 70 Degrees Celsius
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: 498ae565-8b4c-4386-9eb0-cf50ae55e8a5
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 01, 2023