Catalog Number

01.1624.001

Brand Name

S-Monovette®

Version/Model Number

01.1624.001

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

-

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

df29c612-448d-4bb4-90ba-383e3f1bcea9

Public Version Date

April 01, 2020

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

04038917228299

Quantity per Package

500

Contains DI Package

04038917228305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-