Catalog Number

364958

Brand Name

BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube

Version/Model Number

364958

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

K024240,K024240,K024240

Product Code

JSM

Product Code Name

CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Public Device Record Key

f43b0cd2-e397-439d-a11b-c4a29eb203cf

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

November 16, 2020

Package DI Number

30382903649588

Quantity per Package

100

Contains DI Package

50382903649582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack