Catalog Number

701068046

Brand Name

Table Line Pack

Version/Model Number

BO-T 25106

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 22, 2019

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)

Yes

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

-

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

ce94e917-d5f3-4644-b32e-bb2023c1aef7

Public Version Date

February 22, 2019

Public Version Number

5

DI Record Publish Date

November 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-