Catalog Number

366643

Brand Name

BD Vacutainer® EDTA (K2) Blood Collection Tubes

Version/Model Number

366643

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

BK050036,BK050036

Product Code

GIM

Product Code Name

Tubes, vacuum sample, with anticoagulant

Public Device Record Key

e3d98245-746b-45e0-a5c2-29eec5a6405f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-