PORTRAIT HSWXB 5700219-11

GUDID 00195278697165

Portrait HSWXB Medical Software

GE Healthcare Finland Oy

Physiologic monitor-installed software

• Primary Device ID: 00195278697165
• NIH Device Record Key: 8727f277-8bcc-44ae-96b5-7720893e5226
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTRAIT HSWXB
• Version Model Number: HSWXB
• Catalog Number: 5700219-11
• Company DUNS: 401966697
• Company Name: GE Healthcare Finland Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278697165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234130

FDA Product Code

• MWI: Monitor, physiological, patient (without arrhythmia detection or alarms)

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: 2024-05-08
• Device Publish Date: 2024-04-30

On-Brand Devices [PORTRAIT HSWXB]

• 00195278697165: Portrait HSWXB Medical Software
• 00198953030981: Portrait HSWXB Medical Software 1.2