Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-43044-01

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"

Yes

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

816f640c-5478-418c-acf9-77257cf2b8b7

Public Version Date

July 02, 2019

Public Version Number

1

DI Record Publish Date

June 24, 2019

Package DI Number

40612479243055

Quantity per Package

5

Contains DI Package

20612479243044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case