Cardiohelp 70107.3079

GUDID 04058863084336

CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting the CARDIOHELP Base Plate or CARDIOHELP Wall Holder incl. CARD

Maquet Cardiopulmonary AG

Medical device service rail

• Primary Device ID: 04058863084336
• NIH Device Record Key: 36a80d22-16a7-4375-b745-7b8d14760738
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiohelp
• Version Model Number: Mobile Holder HKH 8860
• Catalog Number: 70107.3079
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058863084336 [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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-01

On-Brand Devices [Cardiohelp]

• 04058863084336: CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting the CARD
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