Catalog Number

01.1613.100

Brand Name

S-Monovette®

Version/Model Number

01.1613.100

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

b0608541-c0c1-4493-af3b-9cf05d3dcff7

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

04038917024242

Quantity per Package

500

Contains DI Package

04038917132107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-