Catalog Number

BAT3015

Brand Name

N/A

Version/Model Number

BAT3015

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"

Yes

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

6074b6d5-d973-4dd1-a099-338d45e37fff

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2017

Package DI Number

50885403056947

Quantity per Package

10

Contains DI Package

10885403056949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case