Catalog Number

01.1621.001

Brand Name

S-Monovette®

Version/Model Number

01.1621.001

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

PJE

Product Code Name

Blood/Plasma Collection Device For Dna Testing

Public Device Record Key

f6992fc1-ab35-4b60-ac46-b66000b7cbca

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

October 11, 2018

Package DI Number

04038917312691

Quantity per Package

10

Contains DI Package

04038917312707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-