Catalog Number

-

Brand Name

HARVEST® SmartPrep®

Version/Model Number

51494

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

-

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

K103340

Product Code

JQC

Product Code Name

CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Public Device Record Key

d7a2c95c-4eed-4808-bc41-cca8e4ec9ec3

Public Version Date

September 02, 2022

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-