Catalog Number

364956

Brand Name

BD Vacutainer® Urine Complete Cup Kit

Version/Model Number

364956

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

Yes

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

-

FDA Premarket Submission

K024240,K024240

Product Code

JSM

Product Code Name

CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Public Device Record Key

8c22329a-ac4b-44b1-9f27-df7f2f2dbfa8

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

November 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-