PORTRAIT RRP01 5514119

GUDID 00195278229229

BODY-WORN RESP ELECTRODE PATCH

GE Healthcare Finland Oy

Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use

Primary Device ID	00195278229229
NIH Device Record Key	ac985d79-488f-47b9-a60b-fd86330adf8f
Commercial Distribution Status	In Commercial Distribution
Brand Name	PORTRAIT RRP01
Version Model Number	RRP01
Catalog Number	5514119
Company DUNS	401966697
Company Name	GE Healthcare Finland Oy
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278223401 [Primary]
GS1	00195278229229 [Package] Contains: 00195278223401 Package: [30 Units] In Commercial Distribution
GS1	00195278699893 [Package] Contains: 00195278223401 Package: [30 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230626

FDA Product Code

DQA

Oximeter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2024-01-03
Device Publish Date	2023-09-12

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00195278229229 - PORTRAIT RRP01	2024-01-03BODY-WORN RESP ELECTRODE PATCH
00195278229229 - PORTRAIT RRP01	2024-01-03 BODY-WORN RESP ELECTRODE PATCH
00195278699916 - PORTRAIT AAB01	2023-11-03 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
00195278699923 - PORTRAIT MMP01	2023-11-03 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
00195278093998 - PORTRAIT HUB01	2023-09-11 HUB, AMBULATORY HUB DEVICE ASSEMBLY
00195278094001 - PORTRAIT BCH01	2023-09-11 CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY
00195278110435 - PORTRAIT MMP01	2023-09-11 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS