Catalog Number

ASK-04001-VAMC

Brand Name

ARROW

Version/Model Number

IPN029608

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041153,K041153

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

2e49168a-94c4-4e63-b937-f6a6946470d1

Public Version Date

February 19, 2020

Public Version Number

2

DI Record Publish Date

October 15, 2018

Package DI Number

20801902143574

Quantity per Package

5

Contains DI Package

10801902143577

Package Discontinue Date

January 08, 2020

Package Status

Not in Commercial Distribution

Package Type

Case