Cardiohelp

Basic Information

• Brand Name: Cardiohelp
• Primary DI: 04037691260730
• Version / Model: MTK 20-554 Medex LogiCal Transducer Holder
• Catalog Number: 701020721
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-30
• Public Version: 1
• Public Version Date: 2021-10-08
• Public Version Status: New
• Public Device Record Key: 55b4289d-b2ef-491c-a503-8337de5f3d6b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	870.4220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35099	Cardiopulmonary bypass system, roller type	An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with roller pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, a defoamer, and a handcrank for manual emergency rotation of a blood pump. Some systems are manufactured as a single unit while others are made up of modules.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691260730	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K102726	000