Catalog Number

-

Brand Name

EXPRESS

Version/Model Number

16400

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K984496,K984496

Product Code

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

00739cb5-22b0-4917-b6ad-87e063d49a30

Public Version Date

October 15, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2015

Package DI Number

20650862164002

Quantity per Package

6

Contains DI Package

00650862164008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-