Catalog Number

ED221-NO

Brand Name

CARDINAL HEALTH

Version/Model Number

ED221-NO

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

K071785,K071785,K071785

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

909014b6-4fb9-41b9-ba73-bb485b514c57

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 29, 2016

Package DI Number

35019517065743

Quantity per Package

100

Contains DI Package

15019517065749

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX