NA

Basic Information

• Brand Name: NA
• Primary DI: 04037691645155
• Version / Model: CARDIOHELP Emergency Drive Holder, Mast
• Catalog Number: 70104.8006
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a293ab57-cf50-4dd2-9f91-9322b1553cce

Device Description

CARDIOHELP Emergency Drive Holder for mast

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
35954	Medical device service rail	A device designed to provide a secure, rapid, and safe method of mounting and organizing medical and non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in hospital wards, treatment rooms or an intensive care unit (ICU). It is usually fixed to a medical device service rail system, a medical device, or directly to a wall and in some cases it may be fixed to mobile devices. It will have a preformed cross-section incorporating a safety design compatible to the clamps expected to be mounted. It may be supplied in regular lengths which must be cut accordingly when fitted, or in prefabricated lengths.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691645155	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102726	000