PORTRAIT SpO2 P-SP01 2104045-001

GUDID 00195278264794

PORTRAIT SpO2 P-SP FINAL DEVICE ASSEMBLY

GE Healthcare Finland Oy

Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor Pulse oximeter probe/processor

• Primary Device ID: 00195278264794
• NIH Device Record Key: 1c3d3ddb-e46f-4ec2-a749-a0a807893d48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTRAIT SpO2 P-SP01
• Version Model Number: P-SP01
• Catalog Number: 2104045-001
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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 Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278264794 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-11
• Device Publish Date: 2023-09-01

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• 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
• 00195278201980 - PORTRAIT AAB01: 2023-09-11 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
• 00195278264794 - PORTRAIT SpO2 P-SP01: 2023-09-11PORTRAIT SpO2 P-SP FINAL DEVICE ASSEMBLY
• 00195278264794 - PORTRAIT SpO2 P-SP01: 2023-09-11 PORTRAIT SpO2 P-SP FINAL DEVICE ASSEMBLY