Catalog Number

-

Brand Name

NA

Version/Model Number

S1001-6010

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

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

d1bd62da-6059-437f-aa7d-b6251b062b35

Public Version Date

March 31, 2020

Public Version Number

4

DI Record Publish Date

March 22, 2017

Package DI Number

04713616090087

Quantity per Package

5

Contains DI Package

04713616093606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-