Catalog Number

4502-50004

Brand Name

easycare

Version/Model Number

4502-50004

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

LRS

Product Code Name

I.V. Start Kit

Public Device Record Key

fc3732a6-d125-4440-ad54-fea8197e02c6

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

Package DI Number

00850015884177

Quantity per Package

100

Contains DI Package

00850015884139

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case