Catalog Number

B1029-56D

Brand Name

Bartels

Version/Model Number

B1029-56D

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K834125

Product Code

JSM

Product Code Name

Culture Media, Non-Propagating Transport

Public Device Record Key

1a01a30f-2146-444c-bde6-bd2233600399

Public Version Date

November 06, 2019

Public Version Number

4

DI Record Publish Date

May 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-