Capacitive Level Sensor 701010855

GUDID 04037691253114

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04037691253114
• NIH Device Record Key: bcbae021-1b5c-46c9-9f7f-28fb143dbc92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capacitive Level Sensor
• Version Model Number: 20-535
• Catalog Number: 701010855
• Company DUNS: 316153865
• Company Name: Maquet Cardiopulmonary AG
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	04037691253114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943803

FDA Product Code

• DTQ: Console, Heart-Lung Machine, Cardiopulmonary Bypass

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: 2020-12-16
• Device Publish Date: 2020-12-08

Devices Manufactured by Maquet Cardiopulmonary AG

• 04037691002583 - NA: 2024-09-30
• 04037691349190 - BMU 40: 2024-09-30
• 04037691349206 - BMU 40: 2024-09-30
• 04037691349213 - BMU 40: 2024-09-30
• 04037691349220 - BMU 40: 2024-09-30
• 04037691349237 - BMU 40: 2024-09-30
• 04037691349244 - BMU 40: 2024-09-30
• 04037691456584 - NA: 2024-09-30 Wall holder for ambulance. Mandatory for ambulance transportation.