QUART

Basic Information

• Brand Name: QUART
• Primary DI: 04037691173412
• Version / Model: BEQ-HBF 140 Arterial Filter, Sterile
• Catalog Number: 70101.2811
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 6
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 2246788a-fb27-4498-a8f6-d1d8c4af61b7
• Distribution End Date: 2020-04-30

Device Description

QUART Arterial Filter with BIOLINE Coating, Sterile. The QUART arterial filter (HBF 140) is a screen filter with integrated bypass and pre-postdeairing mechanic. It is used for removing gaseous embolisms and aggregates from blood components of the arterial bloodline during extracorporeal circulation. Therefore utilization of the arterial filter reduces the patient’s risk of injury from a micro embolism caused by gases or solids.

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
DTM	Filter, blood, cardiopulmonary bypass, arterial line	Cardiovascular	870.4260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35071	Blood transfusion filter	A microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691173412	GS1
Package	04037691173405	GS1		8	Not in Commercial Distribution	2020-04-30

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082544	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	570	Square centimeter
Device Size Text, specify			maximum blood flow [l/min] 7 0
Device Size Text, specify			connection size inlet 3/8 Inch
Device Size Text, specify			connection size outlet 3/8 Inch
Device Size Text, specify			priming volume 180 Milliliter
Pore Size	40	Micrometer