Catalog Number

K215SDF-BB-BF

Brand Name

K2 Scientific, LLC

Version/Model Number

K215SDFBBBF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Public Device Record Key

b1ec7a89-75a7-423f-9dd4-1fffa9c43cc6

Public Version Date

September 13, 2021

Public Version Number

1

DI Record Publish Date

September 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-