Catalog Number

MS64832

Brand Name

CORMIX

Version/Model Number

MS64832

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 28, 2021

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

K030888,K030888,K030888

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

b67b6f94-db3f-4fdc-b695-8eb23073c5f4

Public Version Date

May 31, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

50812496011294

Quantity per Package

5

Contains DI Package

20812496011293

Package Discontinue Date

May 28, 2021

Package Status

Not in Commercial Distribution

Package Type

Cardboard Carton