Catalog Number

-

Brand Name

IV Administration Set

Version/Model Number

HLS104288

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

baf08bed-faca-4193-8258-76bbce63d59e

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

March 16, 2017

Package DI Number

20876604000371

Quantity per Package

4

Contains DI Package

10876604000374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case