Catalog Number

-

Brand Name

TrueCare Biomedix

Version/Model Number

TCBINF042

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,K111351

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

67685660-6a54-4dd6-aa14-63821f187b2d

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

20850789007660

Quantity per Package

300

Contains DI Package

10850789007663

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case