Catalog Number

-

Brand Name

Plateletworks Combo-15 Kit

Version/Model Number

5850

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

K023761

Product Code

JOZ

Product Code Name

SYSTEM, AUTOMATED PLATELET AGGREGATION

Public Device Record Key

87b012f3-0fcb-4f83-bfce-e470a24b3b0e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-