Catalog Number

800-0615

Brand Name

BioCUE®

Version/Model Number

800-0615

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

BK100027

Product Code

JQC

Product Code Name

CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Public Device Record Key

ef50480b-9e47-40bb-9e3f-d6a9395a456a

Public Version Date

April 21, 2020

Public Version Number

4

DI Record Publish Date

November 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-