Catalog Number

-

Brand Name

Cleo

Version/Model Number

21-7222-24

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

K042172,K042172

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

88edbb44-ebd6-4340-9c38-b4f7013f49a8

Public Version Date

October 17, 2018

Public Version Number

6

DI Record Publish Date

November 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-