AccessGUDID - DEVICE: PORTRAIT RRP01 (00195278223401)

GUDID

Device Identifier (DI) Information

Brand Name: PORTRAIT RRP01
Version or Model: RRP01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5514119
Company Name: GE Healthcare Finland Oy

Primary DI Number: 00195278223401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 401966697 *Terms of Use

Device Description: BODY-WORN RESP ELECTRODE PATCH

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:	Yes
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?
61679	Thoracic electrical impedance electrode array, single-use	A noninvasive configuration of multiple electrodes (e.g., patches, belt-like) intended to be affixed to the thorax to perform continuous bioimpedance measurements for assessment of lung function (e.g., respiratory rate) or pulmonary conditions (e.g., atelectasis, pneumothorax, endotracheal tube misplacement) of a ventilated or spontaneous breathing patient; it is intended to be used in conjunction with a parent device [e.g., monitor, thoracic electrical impedance tomography (EIT) or segmentography system]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)
MSX	System, network and communication, physiological monitors
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 10 and 30 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: ac985d79-488f-47b9-a60b-fd86330adf8f
Public Version Date: January 03, 2024
Public Version Number: 2
DI Record Publish Date: September 12, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00195278229229	30	00195278223401		In Commercial Distribution
00195278699893	30	00195278223401		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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