Catalog Number

-

Brand Name

Medichoice

Version/Model Number

CLC1097

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

-

Product Code

PEZ

Product Code Name

Central venous catheter dressing change kit

Public Device Record Key

237c7c6b-ce72-4021-9de7-b37d0c3be363

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

50885632125841

Quantity per Package

30

Contains DI Package

10885632125843

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-