Level Sensor Pads 701022208

GUDID 04037691687308

Level Sensor Pads LSP 20-531, non-sterile, box of 100 pieces

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type

• Primary Device ID: 04037691687308
• NIH Device Record Key: a1400dd4-ba6f-4232-9b8c-83a4aac7ac1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Level Sensor Pads
• Version Model Number: LSP 20-531
• Catalog Number: 701022208
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691687308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102726

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

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• 04037691032528 - NA: 2023-06-02
• 04037691576640 - Quadrox-iD: 2022-12-13
• 04037691588285 - HLS Set: 2022-12-13
• 04037691741130 - NA: 2022-12-08
• 04037691741543 - NA: 2022-12-08
• 04037691773513 - NA: 2022-12-08
• 04037691009025 - NA: 2022-12-06