Catalog Number

701048448

Brand Name

10ft 3/8 x 3/32 Tubing 68A

Version/Model Number

T 20105

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 11, 2020

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"

Yes

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

DWE

Product Code Name

Tubing, Pump, Cardiopulmonary Bypass

Public Device Record Key

ee31f7b5-ec16-48f7-80d5-e0fa958261bc

Public Version Date

December 14, 2020

Public Version Number

5

DI Record Publish Date

March 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-