MAQUET CARDIOHELP 70105.5721

GUDID 04037691816449

MAQUET CARDIOHELP Bubble Sensor BS 3/8x1/16-1/4x3/32 L1.7

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system air bubble/fluid level detector

• Primary Device ID: 04037691816449
• NIH Device Record Key: 9c65dd3b-2a17-4d59-a18f-9cccf8736b8e
• Commercial Distribution Discontinuation: 2024-09-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MAQUET CARDIOHELP
• Version Model Number: BS 3/8x1/16-1/4x3/32 L1.7
• Catalog Number: 70105.5721
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691816449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133598

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-09-30
• Device Publish Date: 2017-01-10

On-Brand Devices [MAQUET CARDIOHELP]

• 04058863112176: CARDIOHELP Emergency Drive
• 04037691816449: MAQUET CARDIOHELP Bubble Sensor BS 3/8x1/16-1/4x3/32 L1.7
• 04037691643526: CARDIOHELP Emergency Drive