Catalog Number

800-0516

Brand Name

Plasmax® Plasma Concentration Kit

Version/Model Number

800-0516

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"

-

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

BK070026

Product Code

KSS

Product Code Name

SUPPLIES, BLOOD-BANK

Public Device Record Key

4aeba5a4-0e35-4a26-8b49-1818f2490ffb

Public Version Date

July 23, 2020

Public Version Number

3

DI Record Publish Date

November 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-