Catalog Number

800-0710

Brand Name

Bilateral BMA Kit

Version/Model Number

800-0710

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

LWE

Product Code Name

Bone marrow collection/transfusion kit

Public Device Record Key

8b9fc76c-567a-4ff9-97e3-6713e904811f

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-