Catalog Number

MED 5021

Brand Name

Vacuflow™

Version/Model Number

MED 5021

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K000714,K000714,K000714

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

990bfd8b-437f-4b57-843e-ffd9c535ffeb

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

August 15, 2016

Package DI Number

10850011007003

Quantity per Package

50

Contains DI Package

00850011007006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack