Catalog Number

-

Brand Name

Horizon Series™

Version/Model Number

PC100h

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KSH

Product Code Name

Chamber, Environmental For The Storage Of Platelet Concentrate

Public Device Record Key

33423dd6-737d-41ff-8930-6a40a56f0586

Public Version Date

August 18, 2021

Public Version Number

4

DI Record Publish Date

July 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-