Catalog Number

4505K

Brand Name

Bone Marrow Kit

Version/Model Number

4505K

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

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

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

2510d9de-f978-48f8-8257-2372afe3ad7d

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

September 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-