Catalog Number

663028

Brand Name

BD

Version/Model Number

663028

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2021

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

-

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

K970836

Product Code

GKZ

Product Code Name

Counter, differential cell

Public Device Record Key

7b4eb971-b8cc-48ce-9e68-cf65c8ab2261

Public Version Date

April 19, 2021

Public Version Number

4

DI Record Publish Date

January 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-