70106.6547

GUDID 04058863039725

Maquet Cardiopulmonary AG

Haemoconcentrator

• Primary Device ID: 04058863039725
• NIH Device Record Key: 36302530-29d0-488a-bf25-3c3f313f0bd4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BC 140 Plus HEMOCONCENTRATOR
• Catalog Number: 70106.6547
• 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
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04058863030906 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	04058863039725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123288

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-20

Devices Manufactured by Maquet Cardiopulmonary AG

• 04037691645148 - NA: 2024-12-11 CARDIOHELP Emergency Drive Holder for rail
• 04037691645155 - NA: 2024-12-11 CARDIOHELP Emergency Drive Holder for mast
• 04037691720791 - NA: 2024-12-11 CARDIOHELP Holder for mast
• 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