AccessGUDID - DEVICE: NA (04037691209722)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: VBT Venous Bubble Trap
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70102.9805
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691209722
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: No description.

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: 14449628-98a1-4871-9e48-1815f1dc4be9
Public Version Date: September 30, 2024
Public Version Number: 5
DI Record Publish Date: October 24, 2015