Catalog Number

-

Brand Name

MediChoice

Version/Model Number

IVS2036

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

K923361,K923361

Product Code

LRS

Product Code Name

I.V. start kit

Public Device Record Key

4c9077a6-c129-48fa-8092-29151760ddb5

Public Version Date

October 20, 2020

Public Version Number

1

DI Record Publish Date

October 12, 2020

Package DI Number

20885632141550

Quantity per Package

100

Contains DI Package

10885632141553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-