AccessGUDID - DEVICE: VBT Venous Bubble Trap (04037691075051)

GUDID

Device Identifier (DI) Information

Brand Name: VBT Venous Bubble Trap
Version or Model: BEQ-VBT 160, BIOLINE, Sterile
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70103.0884
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691075051
Issuing Agency: GS1
Commercial Distribution End Date: September 25, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTP	Defoamer, cardiopulmonary bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: e035d8d8-5df8-4a88-ab01-3d5ae8514276
Public Version Date: September 30, 2024
Public Version Number: 5
DI Record Publish Date: March 13, 2017