Catalog Number

ED3201-CM

Brand Name

CARDINAL HEALTH

Version/Model Number

ED3201-CM

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

34277767-d585-43e4-b119-9e02cae772e3

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 29, 2016

Package DI Number

55019517065853

Quantity per Package

8

Contains DI Package

35019517065859

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE