Catalog Number

-

Brand Name

Westcliff Medical Products

Version/Model Number

WC6018

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 07, 2099

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KST

Product Code Name

System, Blood Collection, Vacuum-Assisted, Manual

Public Device Record Key

29294564-fcc6-479a-8462-d64d9b2b2dbf

Public Version Date

May 27, 2019

Public Version Number

1

DI Record Publish Date

May 17, 2019

Package DI Number

10862572000355

Quantity per Package

200

Contains DI Package

00862572000358

Package Discontinue Date

May 07, 2099

Package Status

In Commercial Distribution

Package Type

Box