GUDID 00198953049181

ICCO CONTINUOUS CARDIAC OUTPUT CABLE, M1154585

GE Healthcare Finland Oy

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00198953049181
• NIH Device Record Key: 9c036465-c05e-4fbb-8f48-4cf929516e88
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PiCCO Continuous Cardiac Output Cable
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00198953049181 [Primary]
GS1	00840682103039 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132528

FDA Product Code

• DXG: Computer, Diagnostic, Pre-Programmed, Single-Function

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: 2026-01-13
• Device Publish Date: 2026-01-05

Devices Manufactured by GE Healthcare Finland Oy

• 00198953049181 - NA: 2026-01-13ICCO CONTINUOUS CARDIAC OUTPUT CABLE, M1154585
• 00198953049181 - NA: 2026-01-13 ICCO CONTINUOUS CARDIAC OUTPUT CABLE, M1154585
• 00198953066560 - NA: 2026-01-13 PICCO INJECTATE SENSOR CABLE, M1182448
• 00198953030981 - PORTRAIT HSWXB: 2025-12-18 Portrait HSWXB Medical Software 1.2
• 00195278984784 - TruSignal SpO2: 2025-06-24 TRUSIGNAL SPO2 TS-G3
• 00195278697165 - PORTRAIT HSWXB: 2024-05-08 Portrait HSWXB Medical Software
• 00195278713193 - Portrait HUBXB: 2024-05-08 Portrait Mobile Patient Monitor Hardware HUBXB
• 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