NA

Basic Information

• Brand Name: NA
• Primary DI: 04037691209722
• Version / Model: VBT Venous Bubble Trap
• Catalog Number: 70102.9805
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 4
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 14449628-98a1-4871-9e48-1815f1dc4be9

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	04037691032528	GS1		8	In Commercial Distribution
Primary	04037691209722	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