Catalog Number

-

Brand Name

Stradis Medical,LLC.

Version/Model Number

HCT222CK-3A

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

26a5c680-922c-4197-97eb-9c1e4b54d624

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Package DI Number

M752HCT222CK3A5

Quantity per Package

30

Contains DI Package

M752HCT222CK3A0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER BOX