ROTAFLOW 70104.7553

GUDID 04037691650333

BO-RF-32-USA#RotaFlow Centrifugal Pump with SOFTLINE Coating

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 04037691650333
• NIH Device Record Key: 5bd5800b-b14d-4d03-bb8a-305256fb23ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROTAFLOW
• Version Model Number: Centrifugal Pump, SOFTLINE
• Catalog Number: 70104.7553
• 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

Customer Support Contacts

• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691650326 [Primary]
GS1	04037691650333 [Package]; Contains: 04037691650326; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090515

FDA Product Code

• KFM: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-19
• Device Publish Date: 2015-10-30

On-Brand Devices [ROTAFLOW]

• 04037691650333: BO-RF-32-USA#RotaFlow Centrifugal Pump with SOFTLINE Coating
• 04037691530871: BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating
• 04037691000824: Centrifugal Pump, USA