Catalog Number

-

Brand Name

TrueCare Biomedix

Version/Model Number

TCBINFGSB12

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111351,K111351

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

97877446-7ec8-4b8d-b427-04c225ca98b5

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

April 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-