Dust filter 20 pcs/pkg

GUDID 17325710004248

Maquet Critical Care AB

Neonatal/adult intensive-care ventilator

• Primary Device ID: 17325710004248
• NIH Device Record Key: f8a8b0a4-b18d-49e4-b0a0-ce6652e47c9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dust filter 20 pcs/pkg
• Version Model Number: 6883441
• Company DUNS: 632707092
• Company Name: Maquet Critical Care AB
• Device Count: 20
• 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: true
• Expiration Date: false
• 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	07325710004241 [Unit of Use]
GS1	17325710004248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192604

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2020-09-24
• Device Publish Date: 2020-09-16

Devices Manufactured by Maquet Critical Care AB

• 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