Catalog Number

AN-04318

Brand Name

ARROW

Version/Model Number

IPN032659

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

K071998,K071998,K071998

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

d816f50c-95a4-47f6-957b-9ba3033120d7

Public Version Date

February 19, 2020

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

20801902003199

Quantity per Package

25

Contains DI Package

00801902003195

Package Discontinue Date

August 08, 2019

Package Status

Not in Commercial Distribution

Package Type

Box