Catalog Number

5450850002

Brand Name

NA

Version/Model Number

5450850002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2024

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

b07d35bc-b8c0-4949-8647-6d0992f06f58

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2017

Package DI Number

37613252027240

Quantity per Package

5

Contains DI Package

07613252027249

Package Discontinue Date

January 01, 2024

Package Status

In Commercial Distribution

Package Type

pack