Catalog Number

CMS-9812

Brand Name

NA

Version/Model Number

CMS-9812

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

K030888,K030888

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

9ac23060-8087-40cd-8a7b-7b0014a88d58

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

50812496011041

Quantity per Package

50

Contains DI Package

00812496011046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Carton