Catalog Number

KIT-OIS

Brand Name

MedStream

Version/Model Number

KIT-OIS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PXG

Product Code Name

Spill Kit

Public Device Record Key

6a73627c-e30f-4bde-ab25-1cb02650eb3a

Public Version Date

November 08, 2018

Public Version Number

1

DI Record Publish Date

October 08, 2018

Package DI Number

10842472106852

Quantity per Package

30

Contains DI Package

00842472106855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-