Catalog Number

-

Brand Name

NA

Version/Model Number

19909

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2021

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

acf23693-9ccb-4875-b187-7bf360a86fb2

Public Version Date

October 12, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2015

Package DI Number

20650862199097

Quantity per Package

10

Contains DI Package

00650862199093

Package Discontinue Date

October 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-