Catalog Number

70102.9805

Brand Name

NA

Version/Model Number

VBT Venous Bubble Trap

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K082412,K082412

Product Code

DTP

Product Code Name

Defoamer, cardiopulmonary bypass

Public Device Record Key

14449628-98a1-4871-9e48-1815f1dc4be9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

04037691032528

Quantity per Package

8

Contains DI Package

04037691209722

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-