Catalog Number

-

Brand Name

Extension Set

Version/Model Number

HLEV23554

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

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

35be2b53-c1d9-4436-b38e-9f4bb7d1b18b

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

March 15, 2017

Package DI Number

20876604001705

Quantity per Package

4

Contains DI Package

10876604001708

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case