Catalog Number

-

Brand Name

SCD®-IIB

Version/Model Number

62002

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

BK860041

Product Code

KSB

Product Code Name

SET, TRANSFER (BLOOD/PLASMA)

Public Device Record Key

f1501b88-b273-439c-8c18-d4116b136c0e

Public Version Date

September 20, 2022

Public Version Number

6

DI Record Publish Date

September 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-