VBT Venous Bubble Trap

Basic Information

• Brand Name: VBT Venous Bubble Trap
• Primary DI: 04037691075051
• Version / Model: BEQ-VBT 160, BIOLINE, Sterile
• Catalog Number: 70103.0884
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 4
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: e035d8d8-5df8-4a88-ab01-3d5ae8514276

Device Description

Venous Bubble Trap, BIOLINE Coating (BEQ), and sterile. The Venous Bubble Trap VBT 160 is designed to remove gross air in the venous line before it is entering the arterial pump and the following components of the extra corporeal circuit (ECC). The VBT has been especially developed as an additional safety feature for minimized systems, e.g. MECC, where venous reservoirs are missing. The VBT is using different physical principals for air removal.

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
DTP	Defoamer, cardiopulmonary bypass	Cardiovascular	870.4230	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
Package	04037691075068	GS1		8	In Commercial Distribution
Primary	04037691075051	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082412	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Connection size 1/2 Inch
Total Volume	160	Milliliter