Catalog Number

LH-0035YN

Brand Name

Port Access Needle

Version/Model Number

LH-0035YN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

5e857391-ce37-4140-a100-721b500d9c00

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 02, 2016

Package DI Number

20801741066294

Quantity per Package

4

Contains DI Package

10801741066297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX