ITS Housing 6882773

GUDID 07325710011140

Maquet Critical Care AB

Thermal-dilution cardiac output unit

• Primary Device ID: 07325710011140
• NIH Device Record Key: 0d5fe893-91c6-4ce2-91de-5c590d913a1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITS Housing
• Version Model Number: PV4046
• Catalog Number: 6882773
• Company DUNS: 632707092
• Company Name: Maquet Critical Care AB
• Device Count: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07325710011140 [Unit of Use]
GS1	27325710011144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020587

FDA Product Code

• KRB: Probe, Thermodilution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-04-01
• Device Publish Date: 2026-03-24

Devices Manufactured by Maquet Critical Care AB

• 07325710011140 - ITS Housing: 2026-04-01
• 07325710011140 - ITS Housing: 2026-04-01
• 07325710011607 - PiCCO catheter: 2026-04-01
• 07325710017043 - PiCCO catheter: 2026-04-01
• 07325710017067 - PiCCO catheter: 2026-04-01
• 07325710017098 - PiCCO catheter: 2026-04-01
• 07325710017104 - PiCCO catheter: 2026-04-01
• 07325710012673 - Drawer for Low mobile carts: 2023-12-18
• 07325710001653 - Compressor Mini 115V 60Hz: 2023-09-29