AccessGUDID - DEVICE: PORTRAIT RR P-RR01 (00195278264817)

GUDID

Device Identifier (DI) Information

Brand Name: PORTRAIT RR P-RR01
Version or Model: P-RR01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2103567-001
Company Name: GE Healthcare Finland Oy

Primary DI Number: 00195278264817
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 401966697 *Terms of Use

Device Description: PORTRAIT RR P-RR 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?
65830	Respiration rate signal processor/transmitter	An electrically-powered device designed to be connected to a thorax-placed electrode array (not included) to collect, process, and wirelessly transmit respiration rate signal data for subsequent display on a separate monitor. It is a small unit with an electrical connection, internal processing functionality, and a transmitter.	Active	false

FDA Product Code

[?]

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

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 -30 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b201507-8e0a-402e-8d99-8d59cb6d7c22
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 01, 2023