Catalog Number

B3109

Brand Name

Lifemed Tubing Recirculating Set

Version/Model Number

B3109

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

-

Product Code

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Public Device Record Key

fbeb7fda-5b40-440e-a025-8be6ffc82434

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

October 06, 2015

Package DI Number

10852250006038

Quantity per Package

50

Contains DI Package

00852250006031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box