Catalog Number

012201NY

Brand Name

Port Access Needle

Version/Model Number

012201NY

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

075feb78-9310-405a-ac96-a29dbd48bdb7

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

January 18, 2016

Package DI Number

10801741065658

Quantity per Package

25

Contains DI Package

00801741065651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA