Catalog Number

-

Brand Name

TRIFURCATED EXTENSION SET

Version/Model Number

BTF-HM-3

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"

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

K090809,K090809

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

7f074c06-6abd-472a-a4b2-aa52bfafb2f1

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

Package DI Number

10810080610207

Quantity per Package

50

Contains DI Package

00810080610200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case