Catalog Number

CMS-9843

Brand Name

NA

Version/Model Number

CMS-9843

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 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

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

263ad09b-be2d-4e76-bef7-dcbe685d7e74

Public Version Date

September 28, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

50812496011102

Quantity per Package

50

Contains DI Package

00812496011107

Package Discontinue Date

September 27, 2021

Package Status

Not in Commercial Distribution

Package Type

Cardboard Carton