BMU 40 701043405

GUDID 04037691469775

Maquet Cardiopulmonary AG

Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor

• Primary Device ID: 04037691469775
• NIH Device Record Key: 7271322f-fa8d-4ed3-ae0b-abd8a6457d8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BMU 40
• Version Model Number: Holder arm 100 mm with adapter plate
• Catalog Number: 701043405
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691469775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090147

FDA Product Code

• DRY: Monitor, Blood-Gas, On-Line, 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: 2021-10-08
• Device Publish Date: 2021-09-30

On-Brand Devices [BMU 40]

• 04037691412238: BMU 40 Blood Monitoring Unit
• 04037691676203: Y-Datacable kit (LEMO 2 x DE9 female) incl. adaptor kit. RS232-Isolator 4KV. The blood monitori
• 04037691469775: Holder arm 100 mm with adapter plate
• 04037691467207: Holder arm 6 mm with adapter plate
• 04037691447445: Holder arm 200 mm with adapter plate