NA

Basic Information

• Brand Name: NA
• Primary DI: 04037691741130
• Version / Model: HIT Set Advanced 7.0, Adult, SOFTLINE Coating
• Catalog Number: 70105.2786
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-12
• Public Version: 4
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 22637bd1-6049-4faa-8185-8e51e0e13490

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTR	HEAT-EXCHANGER, CARDIOPULMONARY BYPASS	Cardiovascular	870.4240	2
DTZ	OXYGENATOR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4350	2
KFM	PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE	Cardiovascular	870.4360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35441	Cardiopulmonary bypass system blood tubing set	A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691741130	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112360	000

Device Sizes

Type	Value	Unit	Text
Total Volume	600	Milliliter
Device Size Text, specify			Connection size 1/2 Inch