Catalog Number

10220

Brand Name

Spectra Optia®

Version/Model Number

10220

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

-

Product Code

LKN

Product Code Name

Separator, Automated, Blood Cell And Plasma, Therapeutic

Public Device Record Key

1ffcaa83-f0da-444e-97ed-2a99fc5ab6ed

Public Version Date

September 01, 2022

Public Version Number

2

DI Record Publish Date

May 05, 2021

Package DI Number

35020583102201

Quantity per Package

6

Contains DI Package

05020583102200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-