Catalog Number

20-02-0028

Brand Name

CHEMETRON

Version/Model Number

20-02-0028

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

d981c026-9bf9-4357-9b84-a0a90cef89f2

Public Version Date

May 05, 2020

Public Version Number

4

DI Record Publish Date

August 17, 2016

Package DI Number

40026072002436

Quantity per Package

4

Contains DI Package

00026072002438

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-