Catalog Number

-

Brand Name

Stradis Medical,LLC.

Version/Model Number

HCT222CK-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

ce398932-2ed4-46ae-96b2-ec5bc7abe3df

Public Version Date

February 06, 2020

Public Version Number

1

DI Record Publish Date

January 29, 2020

Package DI Number

M752HCT222CK35

Quantity per Package

30

Contains DI Package

M752HCT222CK30

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box