Catalog Number

04.1900.100

Brand Name

S-Monovette®

Version/Model Number

04.1900.100

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

ade0bd89-75a2-4465-8698-af922e6cea99

Public Version Date

April 01, 2020

Public Version Number

3

DI Record Publish Date

February 15, 2018

Package DI Number

04038917382090

Quantity per Package

10

Contains DI Package

04038917382106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-